VIDEO SCOPE SYSTEM (LARYNGOSCOPE)
FDA 510(k) clearance K944032 · decided 1995-09-15
Clearance details
- K-number
- K944032
- Device name
- VIDEO SCOPE SYSTEM (LARYNGOSCOPE)
- Applicant
- Jedmed Instrument Co.
- Decision
- Substantially Equivalent
- Date received
- 1994-08-17
- Decision date
- 1995-09-15
- Days to decision
- 394 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
- St.Louis, MO, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Jedmed Instrument Co.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| RIGID TELESCOPES (K943904) | Karl Storz Endoskop GmbH | 1994-10-14 |
| DUALUME LARYNGEAL EXAMINATION TELESCOPE (K790845) | National Medical Technology | 1979-07-24 |
Recalls involving this device
No recalls on record reference this clearance.