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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 K091843
Device Name COMFORT TWIN NASAL MASK
Applicant
RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP
1001 MURRY RIDGE LN.
MURRYSVILLE,  PA  15668
Applicant Contact ZITA A YURKO
Correspondent
RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP
1001 MURRY RIDGE LN.
MURRYSVILLE,  PA  15668
Correspondent Contact ZITA A YURKO
Regulation Number868.5905
Classification Product Code
BZD  
Date Received06/22/2009
Decision Date 09/10/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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