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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilatory Effort Recorder
510(k) Number K973920
Device Name STARDUST
Applicant
Respironics, Inc.
1501 Ardmore Blvd.
Pittsburgh,  PA  15221
Applicant Contact RAJI S KASBEKAR
Correspondent
Respironics, Inc.
1501 Ardmore Blvd.
Pittsburgh,  PA  15221
Correspondent Contact RAJI S KASBEKAR
Regulation Number868.2375
Classification Product Code
MNR  
Date Received10/15/1997
Decision Date 05/14/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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