Arripro 35 St/Tv

FDA 510(k) K973115 · Arnold & Richter Cine Technik

Substantially Equivalent

510(k) numberK973115

Submission

Device name
Arripro 35 St/Tv
Applicant
Arnold & Richter Cine Technik
Munich, DE
Received
August 20, 1997
Decision date
September 2, 1997
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA
Third-party review
Yes

Official FDA 510(k) record

Device classification

Product code
IXC – Illuminator, Radiographic-Film
Device class
Class I (low risk)
Regulation
21 CFR 892.1890
Specialty
Radiology

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Questions and answers

When was Arripro 35 St/Tv cleared by the FDA?

Arripro 35 St/Tv (K973115) received a 510(k) decision of Substantially Equivalent on September 2, 1997, 13 days after the submission was received.

What is the product code of K973115?

The FDA product code is IXC – Illuminator, Radiographic-Film, a Class I (low risk) device regulated under 21 CFR 892.1890.