PMA P990053S006

Device: OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM
Applicant: Covidien, LLC
PMA number: P990053
Supplement: S006
Product code: MMA
Decision date: 2003-01-07
Classification: Oximeter, Fetal Pulse
Generic name: Oximeter, fetal pulse
Approval order statement: APPROVAL FOR AN ALTERNATE MANUFACTURING SITE FOR THE N-400 FETAL PULSE OXIMETER. THE MANUFACTURING SITE IS LOCATED AT NELLCOR PURITAN BENNETT IRELAND, GALWAY, IRELAND.

Current openFDA PMA Record#

Device: OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM
Applicant: Covidien, LLC
PMA number: P990053
Supplement: S006
Product code: MMA
Generic name: Oximeter, fetal pulse
Decision date: 2003-01-07
Decision code: APPR
Date received: 2002-03-26
Supplement type: Normal 180 Day Track
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR AN ALTERNATE MANUFACTURING SITE FOR THE N-400 FETAL PULSE OXIMETER. THE MANUFACTURING SITE IS LOCATED AT NELLCOR PURITAN BENNETT IRELAND, GALWAY, IRELAND.