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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 K961626
Device Name SOLO CPAP SYSTEM
Applicant
RESPIRONICS, INC.
1001 MURRY RIDGE LN.
MURRYSVILLE,  PA  15668
Applicant Contact FRANCIS X DOBSCHA
Correspondent
RESPIRONICS, INC.
1001 MURRY RIDGE LN.
MURRYSVILLE,  PA  15668
Correspondent Contact FRANCIS X DOBSCHA
Regulation Number868.5905
Classification Product Code
BZD  
Date Received04/26/1996
Decision Date 07/18/1996
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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