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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mercury
510(k) Number K913814
Device Name MODEL #05 ANEROID SPHYGMOMANOMETER KIT
Applicant
National Health-Care Equipment, Inc.
144 E. Kingsbridge Rd.
Mount Vernon,  NY  11050
Applicant Contact STEVEN R HERSCH
Correspondent
National Health-Care Equipment, Inc.
144 E. Kingsbridge Rd.
Mount Vernon,  NY  11050
Correspondent Contact STEVEN R HERSCH
Regulation Number872.3070
Classification Product Code
ELY  
Date Received08/26/1991
Decision Date 01/16/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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