Minxray HF70D High Frequency Portable Dental X-Ray Unit
FDA 510(k) K000061 · Minxray, Inc.
510(k) numberK000061
Submission
- Device name
- Minxray HF70D High Frequency Portable Dental X-Ray Unit
- Applicant
- Minxray, Inc.
Northbrook, IL, US - Received
- January 10, 2000
- Decision date
- April 7, 2000
- 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 HF70D High Frequency Portable Dental X-Ray Unit cleared by the FDA?
Minxray HF70D High Frequency Portable Dental X-Ray Unit (K000061) received a 510(k) decision of Substantially Equivalent on April 7, 2000, 88 days after the submission was received.
What is the product code of K000061?
The FDA product code is EHD – Unit, X-Ray, Extraoral With Timer, a Class II (moderate risk) device regulated under 21 CFR 872.1800.