The following data is part of a premarket notification filed by Vitalconnect, Inc. with the FDA for Vitalwatch Software User Interface.
| Device ID | K170973 |
| 510k Number | K170973 |
| Device Name: | VitalWatch Software User Interface |
| Classification | Transmitters And Receivers, Physiological Signal, Radiofrequency |
| Applicant | VitalConnect, Inc. 224 Airport Parkway, Suite 300 San Jose, CA 95110 |
| Contact | Kevin Potgieter |
| Correspondent | Kevin Potgieter 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 | 2017-04-03 |
| Decision Date | 2017-06-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850490007207 | K170973 | 000 |
| 00850490007160 | K170973 | 000 |
| 00850490007139 | K170973 | 000 |
| 00850490007306 | K170973 | 000 |