PMA P040025S013
- Device
- OLYMPIC COOL CAP
- Applicant
- Natus Medical Incorporated
- PMA number
- P040025
- Supplement
- S013
- Product code
- MXM
- Decision date
- 2013-08-29
- Generic name
- Cap, cooling (infants)
- Approval order statement
- APPROVAL FOR A SOFTWARE PATCH THAT ALLOWS THE WATCHDOG TIMER TO REBOOT THE DEVICE AND INITIATE A POWER FAILURE RECOVERY ALARM IN THE EVENT OF A SCREEN FREEZE CONDITION.
Current openFDA PMA Record#
- Device
- OLYMPIC COOL CAP
- Applicant
- Natus Medical Incorporated
- PMA number
- P040025
- Supplement
- S013
- Product code
- MXM
- Generic name
- Cap, cooling (infants)
- Decision date
- 2013-08-29
- Decision code
- APPR
- Date received
- 2013-05-28
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR A SOFTWARE PATCH THAT ALLOWS THE WATCHDOG TIMER TO REBOOT THE DEVICE AND INITIATE A POWER FAILURE RECOVERY ALARM IN THE EVENT OF A SCREEN FREEZE CONDITION.