The following data is part of a premarket notification filed by Companion Medical, Inc. with the FDA for Inpen System.
| Device ID | K201337 |
| 510k Number | K201337 |
| Device Name: | InPen System |
| Classification | Calculator, Drug Dose |
| Applicant | Companion Medical, Inc. 12230 World Trade Drive, Suite 100 San Diego, CA 92128 |
| Contact | Jasper Benke |
| Correspondent | Jasper Benke Companion Medical, Inc. 12230 World Trade Drive, Suite 100 San Diego, CA 92128 |
| Product Code | NDC |
| CFR Regulation Number | 868.1890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-05-20 |
| Decision Date | 2020-06-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 62088-0000-35 | K201337 | 000 |
| 62088-0000-32 | K201337 | 000 |
| 62088-0000-31 | K201337 | 000 |
| 00763000645298 | K201337 | 000 |
| 00763000645281 | K201337 | 000 |