The following data is part of a premarket notification filed by Physiq Inc. with the FDA for Physiq Heart Rhythm Module.
| Device ID | K180234 |
| 510k Number | K180234 |
| Device Name: | PhysiQ Heart Rhythm Module |
| Classification | Electrocardiograph |
| Applicant | physiQ Inc. 300 E. 5th Avenue, Suite 105 Naperville, IL 60563 |
| Contact | George Allen Hides |
| Correspondent | George Allen Hides physiQ Inc. 300 E. 5th Avenue, Suite 105 Naperville, IL 60563 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-01-29 |
| Decision Date | 2018-08-10 |
| Summary: | summary |