Minxray, Model HF100H+
FDA 510(k) K052721 · Minxray, Inc.
510(k) numberK052721
Submission
- Device name
- Minxray, Model HF100H+
- Applicant
- Minxray, Inc.
Deer Field, IL, US - Received
- September 29, 2005
- Decision date
- October 27, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Minxray, Model HF100H+ cleared by the FDA?
Minxray, Model HF100H+ (K052721) received a 510(k) decision of Substantially Equivalent on October 27, 2005, 28 days after the submission was received.
What is the product code of K052721?
The FDA product code is IZL – System, X-Ray, Mobile, a Class II (moderate risk) device regulated under 21 CFR 892.1720.