Philips wearable biosensor-G5 Solution— 510(k) K181165
Substantially EquivalentConnected Sensing- A Division of Philips Medical Systems
FDA 510(k) clearance K181165 for Philips wearable biosensor-G5 Solution, Substantially Equivalent on 2019-03-07. Applicant: Connected Sensing- A Division of Philips Medical Systems. Device class: 2.
Clearance details
- Applicant
- Connected Sensing- A Division of Philips Medical Systems
- Product code
- Code DRT
- Device class
- Class 2
- Regulation
- 21 CFR 870.2300
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cambridge, MA, US
Recent devices under product code DRT
view allAdverse events under product code DRT
product code DRT- Death
- 4
- Total
- 4
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.