Multi-Format Film Camera
FDA 510(k) K843582 · Bfi- Medical Waste Systems
510(k) numberK843582
Submission
- Device name
- Multi-Format Film Camera
- Applicant
- Bfi- Medical Waste Systems
Rolling Meadows, IL, US - Received
- September 11, 1984
- Decision date
- October 25, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Multi-Format Film Camera cleared by the FDA?
Multi-Format Film Camera (K843582) received a 510(k) decision of Substantially Equivalent on October 25, 1984, 44 days after the submission was received.
What is the product code of K843582?
The FDA product code is LMC – Camera, Multi Format, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2040.