The following data is part of a premarket notification filed by Intuity Medical, Inc. with the FDA for Pogo Automatic Blood Glucose Monitoring System.
| Device ID | K162203 |
| 510k Number | K162203 |
| Device Name: | POGO Automatic Blood Glucose Monitoring System |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | Intuity Medical, Inc. 526 Almanor Avenue Sunnyvale, CA 94085 |
| Contact | Robb Hesley |
| Correspondent | Cindy Domecus Domecus Consulting Services LLC 1171 Barroilhet Drive Hillsborough, CA 94010 |
| Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-05 |
| Decision Date | 2017-04-06 |
| Summary: | summary |