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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name ventilator, continuous, facility use
510(k) Number K853300
Device Name HEALTHDYNE IMPLUSE VENTILATOR
Applicant
HEALTHDYNE, INC.
1850 PARKWAY PLACE, 12TH FLOOR
MARIETTA,  GA  30067 -8274
Applicant Contact WILLIAM H DUFFELL
Correspondent
HEALTHDYNE, INC.
1850 PARKWAY PLACE, 12TH FLOOR
MARIETTA,  GA  30067 -8274
Correspondent Contact WILLIAM H DUFFELL
Regulation Number868.5895
Classification Product Code
CBK  
Date Received08/06/1985
Decision Date 08/15/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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