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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 K970173
Device Name MODEL 1700 TRANQUILITY BILEVEL SYSTEM
Applicant
Healthdyne Technologies, Inc.
1850 Pkwy. Pl.
Marietta,  GA  30067
Applicant Contact TIMOTHY Y COWART
Correspondent
Healthdyne Technologies, Inc.
1850 Pkwy. Pl.
Marietta,  GA  30067
Correspondent Contact TIMOTHY Y COWART
Regulation Number868.5905
Classification Product Code
BZD  
Date Received01/16/1997
Decision Date 04/16/1997
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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