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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Non-Continuous (Respirator)
510(k) Number K992192
Device Name AIRPILOTMASK, MODEL TMS-900
Applicant
TIARA MEDICAL SYSTEMS, INC.
14414 DETROIT AVE, SUITE 205
LAKEWOOD,  OH  44107
Applicant Contact GEOFFREY SLEEPER
Correspondent
TIARA MEDICAL SYSTEMS, INC.
14414 DETROIT AVE, SUITE 205
LAKEWOOD,  OH  44107
Correspondent Contact GEOFFREY SLEEPER
Regulation Number868.5905
Classification Product Code
BZD  
Date Received06/29/1999
Decision Date 05/12/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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