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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 K082966
Device Name PB 540 VENTILATOR
Applicant
COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT INC.
6135 Gunbarrel Ave
BOULDER,  CO  80301
Applicant Contact TINA O'BRIEN
Correspondent
COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT INC.
6135 Gunbarrel Ave
BOULDER,  CO  80301
Correspondent Contact TINA O'BRIEN
Regulation Number868.5895
Classification Product Code
CBK  
Date Received10/06/2008
Decision Date 10/31/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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