DUALUME LARYNGEAL EXAMINATION TELESCOPE
FDA 510(k) clearance K790845 · decided 1979-07-24
Clearance details
- K-number
- K790845
- Device name
- DUALUME LARYNGEAL EXAMINATION TELESCOPE
- Applicant
- National Medical Technology
- Decision
- Substantially Equivalent
- Date received
- 1979-05-04
- Decision date
- 1979-07-24
- Days to decision
- 81 days
- Clearance type
- Traditional
- Product code
- ENZ
- Device class
- 2
- Regulation number
- 874.4680
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| VIDEO SCOPE SYSTEM (LARYNGOSCOPE) (K944032) | Jedmed Instrument Co. | 1995-09-15 |
| RIGID TELESCOPES (K943904) | Karl Storz Endoskop GmbH | 1994-10-14 |
Recalls involving this device
No recalls on record reference this clearance.