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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 K922007
Device Name YSI MODEL 441A AIRWAY TEMPERATURE PROBE
Applicant
YELLOW SPRINGS INSTRUMENT CO., INC.
1725 BRANNUM LN.
YELLOW SPRINGS,  OH  45387
Applicant Contact FRED BREIDT
Correspondent
YELLOW SPRINGS INSTRUMENT CO., INC.
1725 BRANNUM LN.
YELLOW SPRINGS,  OH  45387
Correspondent Contact FRED BREIDT
Regulation Number868.1920
Classification Product Code
BZT  
Date Received04/30/1992
Decision Date 11/04/1992
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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