Dry Laser Imager, Drypro Model 832
FDA 510(k) K061999 · Konica Minolta Medical & Graphic, Inc.
510(k) numberK061999
Submission
- Device name
- Dry Laser Imager, Drypro Model 832
- Applicant
- Konica Minolta Medical & Graphic, Inc.
Hachioji-Shi, JP - Received
- July 14, 2006
- Decision date
- August 15, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Dry Laser Imager, Drypro Model 832 cleared by the FDA?
Dry Laser Imager, Drypro Model 832 (K061999) received a 510(k) decision of Substantially Equivalent on August 15, 2006, 32 days after the submission was received.
What is the product code of K061999?
The FDA product code is LMC – Camera, Multi Format, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2040.