The following data is part of a premarket notification filed by Vitalconnect, Inc. with the FDA for Vitalconnect Platform, Vitalpatch Biosensor.
| Device ID | K183078 |
| 510k Number | K183078 |
| Device Name: | VitalConnect Platform, VitalPatch Biosensor |
| Classification | Transmitters And Receivers, Physiological Signal, Radiofrequency |
| Applicant | VitalConnect, Inc. 224 Airport Parkway, Suite 300 San Jose, CA 95110 |
| Contact | Cynthia Merrell |
| Correspondent | Robert Packard Medical Device Academy, Inc. 345 Lincoln Hill Road Shrewsbury, VT 05738 |
| Product Code | DRG |
| Subsequent Product Code | DSI |
| Subsequent Product Code | MHX |
| CFR Regulation Number | 870.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-05 |
| Decision Date | 2019-03-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850490007214 | K183078 | 000 |