The following data is part of a premarket notification filed by Vitalconnect, Inc. with the FDA for Vista Solution Monitoring Kit, Vista Solution 2 10-day Evaluation Kit, Vistatablet 2 (boxed).
| Device ID | K193343 |
| 510k Number | K193343 |
| Device Name: | Vista Solution Monitoring Kit, Vista Solution 2 10-day Evaluation Kit, VistaTablet 2 (Boxed) |
| Classification | Transmitters And Receivers, Physiological Signal, Radiofrequency |
| Applicant | VitalConnect, Inc. 224 Airport Parkway, Suite 300 San Jose, CA 95110 |
| Contact | Cynthia Merrell |
| Correspondent | Cynthia Merrell VitalConnect, Inc. 224 Airport Parkway, Suite 300 San Jose, CA 95110 |
| Product Code | DRG |
| CFR Regulation Number | 870.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-03 |
| Decision Date | 2020-04-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850490007436 | K193343 | 000 |
| 00850490007429 | K193343 | 000 |
| 00850490007399 | K193343 | 000 |
| 00850490007382 | K193343 | 000 |
| 00850490007375 | K193343 | 000 |
| 00850490007467 | K193343 | 000 |
| 00850490007481 | K193343 | 000 |