510(k) K152006
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 5, 2016
- Date Received
- July 21, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Blood Pressure Cuff
- Device Class
- Class II
- Regulation Number
- 870.1120
- Review Panel
- CV
- Submission Type
A blood pressure cuff is a device that has an inflatable bladder in an elastic sleeve (cuff) with a mechanism for inflating the bladder. The cuff is used to determine a subject's blood pressure.