TRACHEAL INTUBATION FIBERVIDEOSCOPE, MODELS LF-Y0004 AND LF-Y0005
FDA 510(k) clearance K082720 · decided 2008-11-05
Clearance details
- K-number
- K082720
- Device name
- TRACHEAL INTUBATION FIBERVIDEOSCOPE, MODELS LF-Y0004 AND LF-Y0005
- Applicant
- Olympus Medical Systems Corporation
- Decision
- Substantially Equivalent
- Date received
- 2008-09-17
- Decision date
- 2008-11-05
- Days to decision
- 49 days
- Clearance type
- Traditional
- Product code
- EOQ
- Device class
- 2
- Regulation number
- 874.4680
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Center Valley, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Mobile airway scope-diagnosis and observation to access airway anatomy, endotracheal/endob recall (Z-0340-2024) | Aizu Olympus Co., Ltd. | 2023-11-17 |
| Olympus Airway Mobilescope, Models MAF-GM & MAF-TM. recall (Z-2495-2023) | Olympus Corporation of the Americas | 2023-08-31 |