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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 K983572
Device Name SIMON MULTICHANNEL RECORDING SYSTEM, MODEL 5500
Applicant
Healthdyne Technologies, Inc.
1255 Kennestone Cir.
Marietta,  GA  30066
Applicant Contact BETSY CORTELLONI
Correspondent
Healthdyne Technologies, Inc.
1255 Kennestone Cir.
Marietta,  GA  30066
Correspondent Contact BETSY CORTELLONI
Regulation Number868.2375
Classification Product Code
MNR  
Date Received10/13/1998
Decision Date 03/19/1999
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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