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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Vibration Threshold Measurement
510(k) Number K970180
Device Name VSA 3000 VIBRATORYN SENSORY ANALYZER
Applicant
EARE CONSULTING SERVICE
P.O. BOX 1309
EILAT,  IL 88112
Applicant Contact EMANUEL A ROSEN, M.S., R.PH.
Correspondent
EARE CONSULTING SERVICE
P.O. BOX 1309
EILAT,  IL 88112
Correspondent Contact EMANUEL A ROSEN, M.S., R.PH.
Regulation Number882.1200
Classification Product Code
LLN  
Date Received01/17/1997
Decision Date 04/25/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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