PRODOSE AAD SYSTEM
FDA 510(k) clearance K030747 · decided 2004-04-22
Clearance details
- K-number
- K030747
- Device name
- PRODOSE AAD SYSTEM
- Applicant
- Profile Therapeutics Plc
- Decision
- Substantially Equivalent
- Date received
- 2003-03-10
- Decision date
- 2004-04-22
- Days to decision
- 409 days
- Clearance type
- Abbreviated
- Product code
- CAF
- Device class
- 2
- Regulation number
- 868.5630
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Mccordsville, IN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.