FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Endophys Blood Pressure Monitor
K Number: K160945
·
Decision Sep 26, 2016
Classifications
1
FEI Numbers
97
Registration Numbers
97
Same Product Code
76
Applicant Total
4
Review Days
174
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Basic Information
- Device Name
- Endophys Blood Pressure Monitor
- K Number
- K160945
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1110
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Endophys Holdings, LLC
- Date Received
- April 5, 2016
- Decision Date
- September 26, 2016
- Product Code
- DSK
- 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 |
|---|---|---|---|
| DSK | Computer, Blood-Pressure | FDA class 2 | Cardiovascular |
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