The following data is part of a premarket notification filed by Hmicro, Inc. with the FDA for Lifesignals Wipoint Biosensor_ios Receiver_app System (lifesignals Wipatch & Wiapp System).
| Device ID | K172011 |
| 510k Number | K172011 |
| Device Name: | LifeSignals WiPoint Biosensor_iOS Receiver_App System (LifeSignals WiPatch & WiApp System) |
| Classification | Transmitters And Receivers, Physiological Signal, Radiofrequency |
| Applicant | HMicro, Inc. 39355 California Street, #303 Fremont, CA 94538 |
| Contact | Kim Tompkins |
| Correspondent | Saravanan Balasubramanlan LifeSignals, Inc. 39355 California Street, Suite 305 Fremont, CA 94538 |
| Product Code | DRG |
| Subsequent Product Code | DRT |
| Subsequent Product Code | DRX |
| CFR Regulation Number | 870.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-07-03 |
| Decision Date | 2018-06-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B353LP11103 | K172011 | 000 |
| B353IM12103 | K172011 | 000 |
| B353IM11103 | K172011 | 000 |
| B353CV12452 | K172011 | 000 |
| B353CS124502 | K172011 | 000 |