K192841 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 February 10, 2020, 130 days after receiving the submission on October 3, 2019.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 868.1890.
| 510(k) Number | K192841 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 03, 2019 |
| Decision Date | February 10, 2020 |
| Days to Decision | 130 days |
| Submission Type | Traditional |
| 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 |