K181327 is an FDA 510(k) clearance for the InPen Dose Calculator. 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 July 6, 2018, 49 days after receiving the submission on May 18, 2018.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 868.1890.
| 510(k) Number | K181327 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 18, 2018 |
| Decision Date | July 06, 2018 |
| Days to Decision | 49 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 |