Minxray, Model CMDR-1S and CMDR-1S-MIL
FDA 510(k) K082627 · Minxray, Inc.
510(k) numberK082627
Submission
- Device name
- Minxray, Model CMDR-1S and CMDR-1S-MIL
- Applicant
- Minxray, Inc.
Deer Field, IL, US - Received
- September 9, 2008
- Decision date
- November 7, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Minxray, Model CMDR-1S and CMDR-1S-MIL cleared by the FDA?
Minxray, Model CMDR-1S and CMDR-1S-MIL (K082627) received a 510(k) decision of Substantially Equivalent on November 7, 2008, 59 days after the submission was received.
What is the product code of K082627?
The FDA product code is IZL – System, X-Ray, Mobile, a Class II (moderate risk) device regulated under 21 CFR 892.1720.