K180234 is an FDA 510(k) clearance for the physiQ Heart Rhythm Module. This device is classified as a Electrocardiograph (Class II - Special Controls, product code DPS).
Submitted by Physiq, Inc. (Naperville, US). The FDA issued a Cleared decision on August 10, 2018, 193 days after receiving the submission on January 29, 2018.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2340.
| 510(k) Number | K180234 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 29, 2018 |
| Decision Date | August 10, 2018 |
| Days to Decision | 193 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DPS - Electrocardiograph |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2340 |