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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stethoscope, Esophageal, With Electrical Conductors
510(k) Number K882319
Device Name TELEMETRIC STETHOSCOPE
Applicant
Vital Signs, Inc.
20 Campus Rd.
Totowa,  NJ  07512
Applicant Contact ED GILLEN
Correspondent
Vital Signs, Inc.
20 Campus Rd.
Totowa,  NJ  07512
Correspondent Contact ED GILLEN
Regulation Number868.1920
Classification Product Code
BZT  
Date Received06/06/1988
Decision Date 08/02/1988
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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