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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
Applicant Contact RICHARD CONFER
Correspondent
Respironics, Inc.
1501 Ardmore Blvd.
Pittsburgh,  PA  15221
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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