FDA.report

510(k) K093905

Device
TRILOGY 202 VENTILATOR
Applicant
RESPIRONICS, INC.
510(k) number
K093905
Product code
CBK  
Decision
Substantially Equivalent (SESE)
Decision date
2010-05-12
Date received
2009-12-22
Regulation
868.5895
Classification name
Ventilator, Continuous, Facility Use
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
2
Clearance type
Abbreviated
Statement or summary
Statement
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
JOSEPH OLSAVSKY
Address
1740 Golden Mile Hwy. Murrysville PA US 15146 15146

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF not indicated by FDA · openFDA JSON

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