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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Continuous, Facility Use
510(k) Number K062019
Device Name RESPCARE HYBRID NE FACE MASK, MODEL TBD,; DISPOSABLE, MODEL TBD
Applicant
Innomed Technologies, Inc./Respcare, Inc.
6601 Lyons Rd., Suites B1-B4
Coconut Creek,  FL  33073
Applicant Contact FRANK PELC
Correspondent
Innomed Technologies, Inc./Respcare, Inc.
6601 Lyons Rd., Suites B1-B4
Coconut Creek,  FL  33073
Correspondent Contact FRANK PELC
Regulation Number868.5895
Classification Product Code
CBK  
Date Received07/17/2006
Decision Date 08/17/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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