Matris Instru. Video Imager 1010-

FDA 510(k) K842494 · Matrix Instruments

Substantially Equivalent

510(k) numberK842494

Submission

Device name
Matris Instru. Video Imager 1010-
Applicant
Matrix Instruments
Received
June 26, 1984
Decision date
August 17, 1984
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
IZI – System, X-Ray, Angiographic
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1600
Specialty
Radiology

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More from Surgvision GmbH

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Questions and answers

When was Matris Instru. Video Imager 1010- cleared by the FDA?

Matris Instru. Video Imager 1010- (K842494) received a 510(k) decision of Substantially Equivalent on August 17, 1984, 52 days after the submission was received.

What is the product code of K842494?

The FDA product code is IZI – System, X-Ray, Angiographic, a Class II (moderate risk) device regulated under 21 CFR 892.1600.