PMA P990053S009

Device: OXI FIRST FETAL OXYGEN SATURATION MONITORING SYSTEM
Applicant: Covidien, LLC
PMA number: P990053
Supplement: S009
Product code: MMA
Decision date: 2002-11-25
Classification: Oximeter, Fetal Pulse
Generic name: Oximeter, fetal pulse
Approval order statement: APPROVAL FOR A NEW MANUFACTURING FACILITY LOCATED AT NELLCOR PURITAN BENNETT, INC., MINNEAPOLIS, MINNESOTA. THIS FACILITY WILL PERFORM MANUFACTURING OF THE FSP02-PM FETAL PATIENT MODULES.

Current openFDA PMA Record#

Device: OXI FIRST FETAL OXYGEN SATURATION MONITORING SYSTEM
Applicant: Covidien, LLC
PMA number: P990053
Supplement: S009
Product code: MMA
Generic name: Oximeter, fetal pulse
Decision date: 2002-11-25
Decision code: APPR
Date received: 2002-04-17
Supplement type: Normal 180 Day Track
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR A NEW MANUFACTURING FACILITY LOCATED AT NELLCOR PURITAN BENNETT, INC., MINNEAPOLIS, MINNESOTA. THIS FACILITY WILL PERFORM MANUFACTURING OF THE FSP02-PM FETAL PATIENT MODULES.