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510(k) Premarket Notification - Food and Drug …
- https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K162203
- 510 (k) Number. K162203. Device Name. POGO Automatic Blood Glucose Monitoring System. Applicant. Intuity Medical, Inc. 526 Almanor Avenue. Sunnyvale, CA …
510(k) Premarket Notification - accessdata.fda.gov
- https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?start_search=1&knumber=K181316
- FDA Home; Medical Devices; Databases - 510(k) | DeNovo | Registration & Listing | Adverse Events ... Device Classification Name: system, test, blood glucose, over the …
510(k) Premarket Notification - accessdata.fda.gov
- https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?start_search=221&ProductCode=&KNumber=&Applicant=&DeviceName=&Type=&ClinicalTrials=off&DecisionDateTo=01%2F16%2F2021&Redact510K=&CombinationProducts=&ZNumber=&SortColumn=dn%5Fdesc
- FDA Home; Medical Devices; Databases - 221 to 230 of 500 Results * ... 510(K) Number. Decision Date. polso watch: ... Medical, Ltd. K220351: 11/18/2022 pogo …
Search the Releasable 510(k) Database | FDA
- https://www.fda.gov/medical-devices/510k-clearances/search-releasable-510k-database
- You can search the releasable 510(k) database by Panel, 510(k) number, Product code or Device name. A search query will produce information from the database in the following …
510(k) Premarket Notification - Food and Drug …
- https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K182885
- Device Classification Name. appliance, fixation, spinal intervertebral body. 22. 510 (k) Number. K182885. Device Name. Atlantis™ Anterior Cervical Plate, …
510(k) Devices Cleared in 2021 | FDA
- https://www.fda.gov/medical-devices/510k-clearances/510k-devices-cleared-2021
- 510 (k) Devices Cleared in 2021 | FDA An official website of the United States government Here’s how you know U.S. Food and Drug Administration Search Menu …
Premarket Notification 510(k) | FDA
- https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/premarket-notification-510k
- A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a …
510(k) Clearances | FDA - U.S. Food and Drug …
- https://www.fda.gov/medical-devices/device-approvals-denials-and-clearances/510k-clearances
- Section 510(k) of the Food, Drug and Cosmetic Act requires device manufacturers who must register, to notify FDA of their intent to market a medical device …
Intuity Medical Receives FDA Clearance to Market …
- https://www.prnewswire.com/news-releases/intuity-medical-receives-fda-clearance-to-market-pogo-automatic-blood-glucose-monitoring-system-300257400.html
- Intuity Medical is committed to simplifying diabetes management by developing proprietary and innovative technologies to address common barriers of …
510(k) Submission Process | FDA
- https://www.fda.gov/medical-devices/premarket-notification-510k/510k-submission-process
- After the Acknowledgement Letter is sent, the FDA routes the 510(k) to the appropriate OHT, based on the device type and medical specialty that is listed in the …
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