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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 K972248
Device Name NELLCOR PURITAN BENNETT GEMINI
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 Number868.5895
Classification Product Code
CBK  
Date Received06/16/1997
Decision Date 09/12/1997
Decision SE SUBJECT TO TRACKING REG (ST)
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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