I-NEB INSIGHT AAD SYSTEM
FDA 510(k) clearance K052941 · decided 2005-12-09
Clearance details
- K-number
- K052941
- Device name
- I-NEB INSIGHT AAD SYSTEM
- Applicant
- Profile Therapeutics Plc
- Decision
- Substantially Equivalent
- Date received
- 2005-10-20
- Decision date
- 2005-12-09
- Days to decision
- 50 days
- Clearance type
- Special
- Product code
- CAF
- Device class
- 2
- Regulation number
- 868.5630
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Murrysville, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.