Operative Recording Camera
FDA 510(k) K904113 · Medical Dynamics, Inc.
510(k) numberK904113
Submission
- Device name
- Operative Recording Camera
- Applicant
- Medical Dynamics, Inc.
Englewood, CO, US - Received
- September 6, 1990
- Decision date
- October 30, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- IKO – Hammer, Reflex, Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.1450
- Specialty
- Physical Medicine
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Questions and answers
When was Operative Recording Camera cleared by the FDA?
Operative Recording Camera (K904113) received a 510(k) decision of Substantially Equivalent on October 30, 1990, 54 days after the submission was received.
What is the product code of K904113?
The FDA product code is IKO – Hammer, Reflex, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.1450.