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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 K940493
Device Name HAND ANEROID SPHYGMOMANOMETER
Applicant
Welch Allyn, Inc.
950ld Shoals Rd.
Arden,  NC  28704
Applicant Contact LARRY WILLIAMS
Correspondent
Welch Allyn, Inc.
950ld Shoals Rd.
Arden,  NC  28704
Correspondent Contact LARRY WILLIAMS
Regulation Number870.1120
Classification Product Code
DXQ  
Date Received02/02/1994
Decision Date 07/01/1994
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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