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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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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