510(k) K173044

Reusable Blood Pressure Cuff, Disposable Blood Pressure Cuff by Ningbo Albert Novosino Co., Ltd. — Product Code DXQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 20, 2017
Date Received
September 28, 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.