PMA P990053S007

Device: OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM
Applicant: Covidien, LLC
PMA number: P990053
Supplement: S007
Product code: MMA
Decision date: 2002-04-18
Classification: Oximeter, Fetal Pulse
Generic name: Oximeter, fetal pulse
Approval order statement: CHANGE IN THE MANUFACTURING SITE FOR THE FETAL SENSOR EMITTER, A COMPONENT OF THE OXIFIRST FETAL SENSOR. THE SENSOR EMITTER WILL BE MANUFACTURED AT THE TYCO FACILITY IN INSURGENTES, TIJUANA, MEXICO, WHERE THE FETAL SENSORS ARE MANUFACTURED.

Current openFDA PMA Record#

Device: OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM
Applicant: Covidien, LLC
PMA number: P990053
Supplement: S007
Product code: MMA
Generic name: Oximeter, fetal pulse
Decision date: 2002-04-18
Decision code: OK30
Date received: 2002-04-05
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: CHANGE IN THE MANUFACTURING SITE FOR THE FETAL SENSOR EMITTER, A COMPONENT OF THE OXIFIRST FETAL SENSOR. THE SENSOR EMITTER WILL BE MANUFACTURED AT THE TYCO FACILITY IN INSURGENTES, TIJUANA, MEXICO, WHERE THE FETAL SENSORS ARE MANUFACTURED.