The following data is part of a premarket notification filed by Companion Medical, Inc. with the FDA for Inpen Dose Calculator.
| Device ID | K181327 |
| 510k Number | K181327 |
| Device Name: | InPen Dose Calculator |
| Classification | Calculator, Drug Dose |
| Applicant | Companion Medical, Inc. 16486 Bernardo Center Drive, # 300 San Diego, CA 92128 |
| Contact | Jasper Benke |
| Correspondent | Jasper Benke Companion Medical, Inc. 16486 Bernardo Center Drive, # 300 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 | 2018-05-18 |
| Decision Date | 2018-07-06 |
| Summary: | summary |