510(k) K904113
- Device
- OPERATIVE RECORDING CAMERA
- Applicant
- MEDICAL DYNAMICS, INC.
- 510(k) number
- K904113
- Product code
- IKO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1990-10-30
- Date received
- 1990-09-06
- Regulation
- 890.1450
- Classification name
- Hammer, Reflex, Powered
- Medical specialty
- Physical Medicine
- Review panel
- Physical Medicine
- Device class
- 2
- 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#
- 3013846070
- 9680900
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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