JEDMED CCD-02 VIDEO CAMERA SYSTEM
FDA 510(k) clearance K862034 · decided 1986-06-09
Clearance details
- K-number
- K862034
- Device name
- JEDMED CCD-02 VIDEO CAMERA SYSTEM
- Applicant
- Jedmed Instrument Co.
- Decision
- Substantially Equivalent
- Date received
- 1986-05-29
- Decision date
- 1986-06-09
- Days to decision
- 11 days
- Clearance type
- Traditional
- Product code
- FWD
- Device class
- 1
- Regulation number
- 878.4160
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- St. Louis, MO, 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 |
|---|---|---|
| FDX SOLID STATE VIDEO CAMERA MODEL 5950 (K891236) | Medical Dynamics, Inc. | 1989-04-05 |
| JEDMED MICRO CCD CAMERA SYSTEM (K882166) | Jedmed Instrument Co. | 1988-06-15 |
| JEDMED CCD CAMERA SYSTEM (K862664) | Jedmed Instrument Co. | 1986-07-30 |
| JEDMED MINI-MOS VIDEO CAMERA (K862145) | Jedmed Instrument Co. | 1986-06-13 |
Recalls involving this device
No recalls on record reference this clearance.