NOVAMED MRI CONDITIONAL LARYNGOSCOPE SET
FDA 510(k) clearance K063477 · decided 2007-02-09
Clearance details
- K-number
- K063477
- Device name
- NOVAMED MRI CONDITIONAL LARYNGOSCOPE SET
- Applicant
- Novamed, LLC
- Decision
- Substantially Equivalent
- Date received
- 2006-11-16
- Decision date
- 2007-02-09
- Days to decision
- 85 days
- Clearance type
- Traditional
- Product code
- CCW
- Device class
- 1
- Regulation number
- 868.5540
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Bonita Springs, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.