Xenon Gas Breathing Circuit
FDA 510(k) K952223 · Intertech Resources, Inc.
510(k) numberK952223
Submission
- Device name
- Xenon Gas Breathing Circuit
- Applicant
- Intertech Resources, Inc.
Fort Myers, FL, US - Received
- May 12, 1995
- Decision date
- August 11, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was Xenon Gas Breathing Circuit cleared by the FDA?
Xenon Gas Breathing Circuit (K952223) received a 510(k) decision of Substantially Equivalent on August 11, 1995, 91 days after the submission was received.
What is the product code of K952223?
The FDA product code is IYT – System, Rebreathing, Radionuclide, a Class II (moderate risk) device regulated under 21 CFR 892.1390.