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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 K963250
Device Name PRESSURE VALVE
Applicant
RESPIRONICS, INC.
1001 MURRY RIDGE LN.
MURRYSVILLE,  PA  15668
Applicant Contact FRANCIS DOBSCHA
Correspondent
RESPIRONICS, INC.
1001 MURRY RIDGE LN.
MURRYSVILLE,  PA  15668
Correspondent Contact FRANCIS DOBSCHA
Regulation Number868.5905
Classification Product Code
BZD  
Date Received08/19/1996
Decision Date 11/14/1996
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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