Drystar, Model 4500M
FDA 510(k) K012941 · Agfa Corp.
510(k) numberK012941
Submission
- Device name
- Drystar, Model 4500M
- Applicant
- Agfa Corp.
Rockville, MD, US - Received
- August 31, 2001
- Decision date
- November 29, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Drystar, Model 4500M cleared by the FDA?
Drystar, Model 4500M (K012941) received a 510(k) decision of Substantially Equivalent on November 29, 2001, 90 days after the submission was received.
What is the product code of K012941?
The FDA product code is LMC – Camera, Multi Format, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2040.