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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Blood Pressure Cuff
510(k) Number K874233
Device Name BLOOD PRESSURE SLEEVE W/TUBING
Applicant
Devcom, Inc.
1700 Russell Rd.
Paoli,  PA  19301
Applicant Contact STEVEN GROSS
Correspondent
Devcom, Inc.
1700 Russell Rd.
Paoli,  PA  19301
Correspondent Contact STEVEN GROSS
Regulation Number870.1120
Classification Product Code
DXQ  
Date Received10/15/1987
Decision Date 03/22/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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