Home / 510(k) Clearances / K152801

510(k) K152801

ULTRACHECK SPACELABS ABP CUFF-CHILD, ULTRACHECK SPACELABS ABP CUFF-SMALL ADULT, ULTRACHECK SPACELABS ABP CUFF-ADULT, ULTRACHECK SPACELABS ABP CUFF-LARGE ADULT by Statcorp Medical — Product Code DXQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 27, 2015
Date Received
September 28, 2015
Clearance Type
Special
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.

Other clearances by Statcorp Medical

  • K122365 — ULTRACHECK CURVE BLOOD PRESSURE CUFFS (June 4, 2013)

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