The following data is part of a premarket notification filed by Connected Sensing- A Division Of Philips Medical Systems with the FDA for Philips Wearable Biosensor-g5 Solution.
| Device ID | K181165 |
| 510k Number | K181165 |
| Device Name: | Philips Wearable Biosensor-G5 Solution |
| Classification | Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) |
| Applicant | Connected Sensing- A Division Of Philips Medical Systems 2 Canal Park Cambridge, MA 02141 |
| Contact | Katie Pacheco |
| Correspondent | Katie Pacheco Connected Sensing- A Division Of Philips Medical Systems 2 Canal Park Cambridge, MA 02141 |
| Product Code | DRT |
| Subsequent Product Code | DRX |
| Subsequent Product Code | MHX |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-05-02 |
| Decision Date | 2019-03-07 |