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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, Minimal Ventilatory Support, Facility Use
510(k) Number K955324
Device Name BIPAP S/T-D 30 SYSTEM
Applicant
RESPIRONICS, INC.
1501 ARDMORE BLVD.
PITTSBURGH,  PA  15221 -4401
Applicant Contact FRANCIS X DOBSCHA
Correspondent
RESPIRONICS, INC.
1501 ARDMORE BLVD.
PITTSBURGH,  PA  15221 -4401
Correspondent Contact FRANCIS X DOBSCHA
Regulation Number868.5895
Classification Product Code
MNT  
Date Received11/20/1995
Decision Date 12/20/1996
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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