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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube, Tracheal (W/Wo Connector)
510(k) Number K930741
Device Name ESOPHAGEAL INTUBATION DETECTOR
Applicant
WOLFE-CARNEY MEDICAL
1119 E. ALPINE PL.
SALT LAKE CITY,  UT  84105
Correspondent
WOLFE-CARNEY MEDICAL
1119 E. ALPINE PL.
SALT LAKE CITY,  UT  84105
Regulation Number868.5730
Classification Product Code
BTR  
Date Received02/12/1993
Decision Date 08/07/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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