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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 K982193
Device Name ESOPHAGEAL STETHOSCOPE
Applicant
SHORE MEDICAL, INC.
2037 OAK GLEN DR.
VISTA,  CA  92083
Applicant Contact MARK RICHARDSON
Correspondent
SHORE MEDICAL, INC.
2037 OAK GLEN DR.
VISTA,  CA  92083
Correspondent Contact MARK RICHARDSON
Regulation Number868.1920
Classification Product Code
BZT  
Date Received06/22/1998
Decision Date 09/01/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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