PMA P890034S005

Device: MODEL 1010 ULTRAHIGH FREQUENCY VENTILATOR
Applicant: Covidien
PMA number: P890034
Supplement: S005
Product code: LSZ
Decision date: 1995-12-28
Generic name: VENTILATOR, HIGH FREQUENCY
Approval order statement: APPROVAL FOR AN PROXIMAL MONITORING ENDOTRACHEAL TUBE ADAPTER FOR USE WITH THE ADULT STAR MODEL 1010 ULTRAHIGH FREQUENCY VENTILATOR - THE PROXIMAL MONITORING ADAPTER WILL BE MARKETED UNDER THE NEW TRADE NAME AS THE "PROXIMAL MONITORING ADAPTER"

Current openFDA PMA Record#

Device: MODEL 1010 ULTRAHIGH FREQUENCY VENTILATOR
Applicant: Covidien
PMA number: P890034
Supplement: S005
Product code: LSZ
Generic name: VENTILATOR, HIGH FREQUENCY
Decision date: 1995-12-28
Decision code: APPR
Date received: 1995-06-12
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR AN PROXIMAL MONITORING ENDOTRACHEAL TUBE ADAPTER FOR USE WITH THE ADULT STAR MODEL 1010 ULTRAHIGH FREQUENCY VENTILATOR - THE PROXIMAL MONITORING ADAPTER WILL BE MARKETED UNDER THE NEW TRADE NAME AS THE "PROXIMAL MONITORING ADAPTER"