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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 K943495
Device Name DISPOSABLE ESOPHAGEAL STETHOSCOPE
Applicant
COAST MEDICAL, INC.
1060 NORTH BATAVIA
UNIT H
ORANGE,  CA  92667
Applicant Contact DOUGLASS R MONOGEON
Correspondent
COAST MEDICAL, INC.
1060 NORTH BATAVIA
UNIT H
ORANGE,  CA  92667
Correspondent Contact DOUGLASS R MONOGEON
Regulation Number868.1920
Classification Product Code
BZT  
Date Received07/19/1994
Decision Date 09/08/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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