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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 K964543
Device Name INFRASONICS ADULT VENTILATOR TRENDING OPTION
Applicant
NELLCOR PURITAN BENNETT, INC.
4280 HACIENDA DR.
PLEASANTON,  CA  94588 -2719
Applicant Contact CAROLE MILLER
Correspondent
NELLCOR PURITAN BENNETT, INC.
4280 HACIENDA DR.
PLEASANTON,  CA  94588 -2719
Correspondent Contact CAROLE MILLER
Regulation Number868.5895
Classification Product Code
CBK  
Date Received11/13/1996
Decision Date 02/14/1997
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
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