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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stethoscope, Electronic
510(k) Number K854356
Device Name STETHOSCOPE ELECTRONIC STETHOSCOPE SPHYGMOMANOMETE
Applicant
Fontaine Industries, Inc.
P.O. Box 92612
2700 Panorama Dr. #403
Long Beach,  CA  90809
Applicant Contact HARRY NISHIGUCHI
Correspondent
Fontaine Industries, Inc.
P.O. Box 92612
2700 Panorama Dr. #403
Long Beach,  CA  90809
Correspondent Contact HARRY NISHIGUCHI
Regulation Number870.1875
Classification Product Code
DQD  
Date Received10/29/1985
Decision Date 05/05/1986
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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