Konica Laser Imager, Drypro Model 751/752
FDA 510(k) K013052 · Konica Minolta Medical & Graphic, Inc.
510(k) numberK013052
Submission
- Device name
- Konica Laser Imager, Drypro Model 751/752
- Applicant
- Konica Minolta Medical & Graphic, Inc.
Hachioji-Shi Tokyo, JP - Received
- September 11, 2001
- Decision date
- January 16, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Konica Laser Imager, Drypro Model 751/752 cleared by the FDA?
Konica Laser Imager, Drypro Model 751/752 (K013052) received a 510(k) decision of Substantially Equivalent on January 16, 2002, 127 days after the submission was received.
What is the product code of K013052?
The FDA product code is LMC – Camera, Multi Format, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2040.