DSP Option
FDA 510(k) K945580 · Philips Medical Systems (Cleveland), Inc.
510(k) numberK945580
Submission
- Device name
- DSP Option
- Applicant
- Philips Medical Systems (Cleveland), Inc.
Cleveland, OH, US - Received
- November 14, 1994
- Decision date
- January 30, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was DSP Option cleared by the FDA?
DSP Option (K945580) received a 510(k) decision of Substantially Equivalent on January 30, 1995, 77 days after the submission was received.
What is the product code of K945580?
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.