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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 K990199
Device Name SMARTRECORDER, MODEL 2500
Applicant
Respironics, Inc.
1501 Ardmore Blvd.
Pittsburgh,  PA  15221 -4401
Applicant Contact BETSY CORTELLONI
Correspondent
Respironics, Inc.
1501 Ardmore Blvd.
Pittsburgh,  PA  15221 -4401
Correspondent Contact BETSY CORTELLONI
Regulation Number868.2375
Classification Product Code
MNR  
Date Received01/21/1999
Decision Date 04/19/1999
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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