FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CareEvent inclusive of the CareEvent Mobile Application accessory
K Number: K161164
·
Decision Jun 24, 2016
Classifications
1
FEI Numbers
72
Registration Numbers
72
Same Product Code
116
Applicant Total
107
Review Days
60
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Basic Information
- Device Name
- CareEvent inclusive of the CareEvent Mobile Application accessory
- K Number
- K161164
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2300
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Philips Medical Systems
- Date Received
- April 25, 2016
- Decision Date
- June 24, 2016
- Product Code
- MSX
- 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 |
|---|---|---|---|
| MSX | System, Network And Communication, Physiological Monitors | FDA class 2 | Cardiovascular |
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