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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 K950331
Device Name PRESSURE SUPPORT VENTILATORY ASSIST SYSTEM (PSVAS)
Applicant
Healthdyne, Inc.
1850 Pkwy. Place, 12th Floor
Marietta,  GA  30067 -8274
Applicant Contact TIMOTHY Y COWART
Correspondent
Healthdyne, Inc.
1850 Pkwy. Place, 12th Floor
Marietta,  GA  30067 -8274
Correspondent Contact TIMOTHY Y COWART
Regulation Number868.5905
Classification Product Code
BZD  
Date Received01/27/1995
Decision Date 09/21/1995
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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