510(k) K171889
K171889 is an FDA 510(k) premarket notification submitted by Suzhou Minhua Medical Apparatus Supplies Co., Ltd. for the device "Reusable Blood Pressure Cuff". The FDA issued a decision of Substantially Equivalent on December 19, 2017. The device falls under product code DXQ (Blood Pressure Cuff), a Class II device regulated under 21 CFR 870.1120. Suzhou Minhua Medical Apparatus Supplies Co., Ltd. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 19, 2017
- Date Received
- June 26, 2017
- 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.