PMA P040025S006

Device: OLYMPIC COOL-CAP SYSTEM
Applicant: Natus Medical Incorporated
PMA number: P040025
Supplement: S006
Product code: MXM
Decision date: 2008-02-05
Generic name: Cap, cooling (infants)
Approval order statement: APPROVAL FOR A DESIGN CHANGE TO THE PUMP MOTOR DRIVE AND CHANGES TO THE CONTROL MODULE AND TEMPERATURE SENSOR MODULE TO RELIABLY MEET ELECTRICAL FAST TRANSIENT (EFT) TESTING.

Current openFDA PMA Record#

Device: OLYMPIC COOL-CAP SYSTEM
Applicant: Natus Medical Incorporated
PMA number: P040025
Supplement: S006
Product code: MXM
Generic name: Cap, cooling (infants)
Decision date: 2008-02-05
Decision code: APPR
Date received: 2007-10-24
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR A DESIGN CHANGE TO THE PUMP MOTOR DRIVE AND CHANGES TO THE CONTROL MODULE AND TEMPERATURE SENSOR MODULE TO RELIABLY MEET ELECTRICAL FAST TRANSIENT (EFT) TESTING.