510(k) K092245

ANEROID SPHYGMOMANOMETER WITH STETHOSCOPE, MODEL LD-100 by Honsun (Nantong) Co., Ltd. — Product Code DXQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 28, 2009
Date Received
July 28, 2009
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.