510(k) K884039
- Device
- MEDICAL DYNAMICS SOLID STATE VIDEO CAMERA 5940
- Applicant
- MEDICAL DYNAMICS, INC.
- 510(k) number
- K884039
- Product code
- FWH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1988-10-13
- Date received
- 1988-09-26
- Regulation
- 878.4160
- Classification name
- Camera, Cine, Surgical, 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#
- 3006810260
- 3005778609
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FWH #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K823516 | ESA CAMERA | Concept, Inc. | 1982-12-30 |
Legacy Summary#
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FDA Review#
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