TRU-MR LARYNGOSCOPE SET
FDA 510(k) clearance K062523 · decided 2006-11-17
Clearance details
- K-number
- K062523
- Device name
- TRU-MR LARYNGOSCOPE SET
- Applicant
- Truphatek International, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2006-08-28
- Decision date
- 2006-11-17
- Days to decision
- 81 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
| Record | Firm | Date |
|---|---|---|
| Conditional Fiber Optic Laryngoscope Kit, which contains laryngoscope blades, handles and recall (Z-0758-2007) | Teleflex Medical | 2007-05-02 |