X-Ray Monoblock, Monoblock XRS-60-330
FDA 510(k) K000052 · Dynarad Corp.
510(k) numberK000052
Submission
- Device name
- X-Ray Monoblock, Monoblock XRS-60-330
- Applicant
- Dynarad Corp.
Deer Park, NY, US - Received
- January 7, 2000
- Decision date
- February 10, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was X-Ray Monoblock, Monoblock XRS-60-330 cleared by the FDA?
X-Ray Monoblock, Monoblock XRS-60-330 (K000052) received a 510(k) decision of Substantially Equivalent on February 10, 2000, 34 days after the submission was received.
What is the product code of K000052?
The FDA product code is ITY – Assembly, Tube Housing, X-Ray, Diagnostic, a Class I (low risk) device regulated under 21 CFR 892.1760.