The following data is part of a premarket notification filed by Vital Connect, Inc. with the FDA for Vital Connect Platform, Healthpatch Md, Vitalpatch.
| Device ID | K152139 |
| 510k Number | K152139 |
| Device Name: | Vital Connect Platform, HealthPatch MD, VitalPatch |
| Classification | Transmitters And Receivers, Physiological Signal, Radiofrequency |
| Applicant | VITAL CONNECT, INC. 900 E. HAMILTON AVENUE, SUITE 500 Campbell, CA 95008 |
| Contact | Bonnie Wu |
| Correspondent | Bonnie Wu VITAL CONNECT, INC. 900 E. HAMILTON AVENUE, SUITE 500 Campbell, CA 95008 |
| 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 | 2015-08-03 |
| Decision Date | 2015-12-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850490007177 | K152139 | 000 |
| 00850490007153 | K152139 | 000 |
| 00850490007085 | K152139 | 000 |
| 00850490007061 | K152139 | 000 |
| 20884838085231 | K152139 | 000 |
| 20884838064960 | K152139 | 000 |
| 20884838064953 | K152139 | 000 |