MODIFICATION TO: PNEUTON VENTILATOR
FDA 510(k) clearance K043085 · decided 2004-12-20
Clearance details
- K-number
- K043085
- Device name
- MODIFICATION TO: PNEUTON VENTILATOR
- Applicant
- Airon Corporation
- Decision
- Substantially Equivalent
- Date received
- 2004-11-08
- Decision date
- 2004-12-20
- Days to decision
- 42 days
- Clearance type
- Special
- Product code
- CBK
- Device class
- 2
- Regulation number
- 868.5895
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Melbourne, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.