ACHIEVA VENTILATOR Y-ACH+E, ACHIEVA PS VENTILATOR Y-ACHPS+E, ACHIEVA PSO2 VENTILATOR Y-ACHPS02+E

Ventilator, Continuous, Facility Use

NELLCOR PURITAN BENNETT, INC.

The following data is part of a premarket notification filed by Nellcor Puritan Bennett, Inc. with the FDA for Achieva Ventilator Y-ach+e, Achieva Ps Ventilator Y-achps+e, Achieva Pso2 Ventilator Y-achps02+e.

Pre-market Notification Details

Device IDK002686
510k NumberK002686
Device Name:ACHIEVA VENTILATOR Y-ACH+E, ACHIEVA PS VENTILATOR Y-ACHPS+E, ACHIEVA PSO2 VENTILATOR Y-ACHPS02+E
ClassificationVentilator, Continuous, Facility Use
Applicant NELLCOR PURITAN BENNETT, INC. 2800 NORTHWEST BLVD. Minneapolis,  MN  55441
ContactCheryl Norton
CorrespondentCheryl Norton
NELLCOR PURITAN BENNETT, INC. 2800 NORTHWEST BLVD. Minneapolis,  MN  55441
Product CodeCBK  
CFR Regulation Number868.5895 [🔎]
DecisionSe Subject To Tracking Reg (ST)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-08-28
Decision Date2000-10-18

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10884521145665 K002686 000
10884521706989 K002686 000
10884521706972 K002686 000
10884521648524 K002686 000

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