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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 K964019
Device Name MORPHEE PLUS ALPHA
Applicant
NELLCOR PURITAN BENNETT, INC.
10200 VALLEY VIEW RD.
EDEN PRAIRIE,  MN  55344
Applicant Contact CHRIS HADLAND
Correspondent
NELLCOR PURITAN BENNETT, INC.
10200 VALLEY VIEW RD.
EDEN PRAIRIE,  MN  55344
Correspondent Contact CHRIS HADLAND
Regulation Number868.5905
Classification Product Code
BZD  
Date Received10/07/1996
Decision Date 06/18/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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