DTV-4114 Fluoroscopic Television Camera
FDA 510(k) K881688 · Adac Laboratories
510(k) numberK881688
Submission
- Device name
- DTV-4114 Fluoroscopic Television Camera
- Applicant
- Adac Laboratories
Milpitas, CA, US - Received
- April 19, 1988
- Decision date
- May 18, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was DTV-4114 Fluoroscopic Television Camera cleared by the FDA?
DTV-4114 Fluoroscopic Television Camera (K881688) received a 510(k) decision of Substantially Equivalent on May 18, 1988, 29 days after the submission was received.
What is the product code of K881688?
The FDA product code is IZJ – Camera, X-Ray, Fluorographic, Cine Or Spot, a Class II (moderate risk) device regulated under 21 CFR 892.1620.