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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Changer, Tube, Endotracheal
510(k) Number K102127
Device Name ENDOTRACHEAL TUBE CHANGERS
Applicant
INSTRUMENTATION INDUSTRIES, INC.
2990 INDUSTRIAL BLVD.
BETHEL PARK,  PA  15102
Applicant Contact DORIS WALTER
Correspondent
INSTRUMENTATION INDUSTRIES, INC.
2990 INDUSTRIAL BLVD.
BETHEL PARK,  PA  15102
Correspondent Contact DORIS WALTER
Regulation Number868.5730
Classification Product Code
LNZ  
Date Received07/29/2010
Decision Date 08/27/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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