K201337 is an FDA 510(k) clearance for the InPen System. This device is classified as a Calculator, Drug Dose (Class II - Special Controls, product code NDC).
Submitted by Companion Medical, Inc. (San Diego, US). The FDA issued a Cleared decision on June 18, 2020, 29 days after receiving the submission on May 20, 2020.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 868.1890.
| 510(k) Number | K201337 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 20, 2020 |
| Decision Date | June 18, 2020 |
| Days to Decision | 29 days |
| Submission Type | Special |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | NDC - Calculator, Drug Dose |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.1890 |