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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Nerve, Battery-Powered
510(k) Number K853849
Device Name MEDAR APM FORCE TRANSDUCER
Applicant
Medar Corp., Inc.
P.O. Box N-H
Scarsdale,  NY  10583
Applicant Contact GEORGE STANEC
Correspondent
Medar Corp., Inc.
P.O. Box N-H
Scarsdale,  NY  10583
Correspondent Contact GEORGE STANEC
Regulation Number868.2775
Classification Product Code
BXN  
Date Received09/16/1985
Decision Date 01/03/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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