FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Philips wearable biosensor-G5 Solution
K Number: K181165
·
Decision Mar 7, 2019
Classifications
1
FEI Numbers
103
Registration Numbers
103
Same Product Code
338
Applicant Total
1
Review Days
309
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Basic Information
- Device Name
- Philips wearable biosensor-G5 Solution
- K Number
- K181165
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2300
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Connected Sensing- A Division of Philips Medical Systems
- Date Received
- May 2, 2018
- Decision Date
- March 7, 2019
- Product Code
- DRT
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | FDA class 2 | Cardiovascular |
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