The following data is part of a premarket notification filed by Vivalnk, Inc. with the FDA for Vv330 Continuous Ecg Platform, Vivalnk Adhesive Patch.
| Device ID | K191870 |
| 510k Number | K191870 |
| Device Name: | VV330 Continuous ECG Platform, VivaLNK Adhesive Patch |
| Classification | Transmitters And Receivers, Physiological Signal, Radiofrequency |
| Applicant | VivaLNK, Inc. 51 E. Campbell Ave. Suite 160 Campbell, CA 95008 |
| Contact | Quoi V. Huynh |
| Correspondent | Quoi V. Huynh VivaLNK, Inc. 51 E. Campbell Ave. Suite 160 Campbell, CA 95008 |
| Product Code | DRG |
| CFR Regulation Number | 870.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-07-12 |
| Decision Date | 2020-01-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00865064000157 | K191870 | 000 |