POWERNEB
FDA 510(k) clearance K051964 · decided 2005-12-01
Clearance details
- K-number
- K051964
- Device name
- POWERNEB
- Applicant
- Comedica , Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-07-20
- Decision date
- 2005-12-01
- Days to decision
- 134 days
- Clearance type
- Traditional
- Product code
- NHJ
- Device class
- 2
- Regulation number
- 868.5905
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Plano, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.