PMA P040025S005
- Device
- COOL CAP SYSTEM
- Applicant
- Natus Medical Incorporated
- PMA number
- P040025
- Supplement
- S005
- Product code
- MXM
- Decision date
- 2007-09-21
- Generic name
- Cap, cooling (infants)
- Approval order statement
- REPLACING A MECHANICAL TEST GAUGE WITH AN ELECTRONIC GAUGE AND THE RELEASE OF AN ACCEPTANCE TEST PROCEDURE FOR THE PERIODIC VERIFICATION OF ALL TEST FIXTURES.
Current openFDA PMA Record#
- Device
- COOL CAP SYSTEM
- Applicant
- Natus Medical Incorporated
- PMA number
- P040025
- Supplement
- S005
- Product code
- MXM
- Generic name
- Cap, cooling (infants)
- Decision date
- 2007-09-21
- Decision code
- OK30
- Date received
- 2007-08-24
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- REPLACING A MECHANICAL TEST GAUGE WITH AN ELECTRONIC GAUGE AND THE RELEASE OF AN ACCEPTANCE TEST PROCEDURE FOR THE PERIODIC VERIFICATION OF ALL TEST FIXTURES.