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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 K920699
Device Name REMSTAR WTIH RAMP AND REMOTE MODIFICATION
Applicant
RESPIRONICS, INC.
1501 ARDMORE BLVD.
PITTSBURGH,  PA  15221 -4401
Applicant Contact RICHARD CONFER
Correspondent
RESPIRONICS, INC.
1501 ARDMORE BLVD.
PITTSBURGH,  PA  15221 -4401
Correspondent Contact RICHARD CONFER
Regulation Number868.5905
Classification Product Code
BZD  
Date Received01/29/1992
Decision Date 12/07/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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