Xenamatic Series of Xenon Rebreath Dev

FDA 510(k) K820571 · Diversified P.A.

Substantially Equivalent

510(k) numberK820571

Submission

Device name
Xenamatic Series of Xenon Rebreath Dev
Applicant
Diversified P.A.
Mchenry, IL, US
Received
March 2, 1982
Decision date
March 31, 1982
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
IYT – System, Rebreathing, Radionuclide
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1390
Specialty
Radiology

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Questions and answers

When was Xenamatic Series of Xenon Rebreath Dev cleared by the FDA?

Xenamatic Series of Xenon Rebreath Dev (K820571) received a 510(k) decision of Substantially Equivalent on March 31, 1982, 29 days after the submission was received.

What is the product code of K820571?

The FDA product code is IYT – System, Rebreathing, Radionuclide, a Class II (moderate risk) device regulated under 21 CFR 892.1390.