COOL CAP SYSTEM
FDA premarket approval P040025/S005 · decided 2007-09-21
Approval details
- PMA number
- P040025
- Supplement
- S005
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- COOL CAP SYSTEM
- Generic name
- Cap, cooling (infants)
- Applicant
- Natus Medical Incorporated
- Date received
- 2007-08-24
- Decision date
- 2007-09-21
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- MXM
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Seattle, WA
- 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.
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