Hand Held Dental X-Ray Device
FDA 510(k) K934818 · Dept. of the Army
510(k) numberK934818
Submission
- Device name
- Hand Held Dental X-Ray Device
- Applicant
- Dept. of the Army
Falls Church, VA, US - Received
- October 7, 1993
- Decision date
- January 24, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was Hand Held Dental X-Ray Device cleared by the FDA?
Hand Held Dental X-Ray Device (K934818) received a 510(k) decision of Substantially Equivalent on January 24, 1994, 109 days after the submission was received.
What is the product code of K934818?
The FDA product code is IZL – System, X-Ray, Mobile, a Class II (moderate risk) device regulated under 21 CFR 892.1720.