OPERATIVE RECORDING CAMERA
FDA 510(k) clearance K904113 · decided 1990-10-30
Clearance details
- K-number
- K904113
- Device name
- OPERATIVE RECORDING CAMERA
- Applicant
- Medical Dynamics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1990-09-06
- Decision date
- 1990-10-30
- Days to decision
- 54 days
- Clearance type
- Traditional
- Product code
- IKO
- Device class
- 2
- Regulation number
- 890.1450
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Englewood, CO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.