510(k) K152468
K152468 is an FDA 510(k) premarket notification submitted by Shenzhen Vistar Medical Supplies Co., Ltd. for the device "Reusable Blood Pressure Cuff". The FDA issued a decision of Substantially Equivalent on Oct 29, 2015. The device falls under product code DXQ (Blood Pressure Cuff), a Class II device regulated under 21 CFR 870.1120. Shenzhen Vistar Medical Supplies Co., Ltd. has 1 other 510(k) clearance on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 29, 2015
- Date Received
- Aug 31, 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
- 510(k)
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.