510(k) K891236
- Device
- FDX SOLID STATE VIDEO CAMERA MODEL 5950
- Applicant
- MEDICAL DYNAMICS, INC.
- 510(k) number
- K891236
- Product code
- FWD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1989-04-05
- Date received
- 1989-03-07
- Regulation
- 878.4160
- Classification name
- Camera, Television, Microsurgical, Without Audio
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- JO BREHM
- Address
- 99 Inverness Dr. E. Englewood CO US 80112 80112
FDA Registration Numbers#
- 2938071
- 3027060896
- 9617248
- 9611112
- 2084346
- 1926681
- 3005216736
- 2085947
- 3007532396
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FWD #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K882166 | JEDMED MICRO CCD CAMERA SYSTEM | Jedmed Instrument Co. | 1988-06-15 |
| K862664 | JEDMED CCD CAMERA SYSTEM | Jedmed Instrument Co. | 1986-07-30 |
| K862145 | JEDMED MINI-MOS VIDEO CAMERA | Jedmed Instrument Co. | 1986-06-13 |
| K862034 | JEDMED CCD-02 VIDEO CAMERA SYSTEM | Jedmed Instrument Co. | 1986-06-09 |
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases