Koordinant Angiographic and Operating Room Model X-Ray Table Family

Q: What is the product code of K993947?

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

FDA 510(k) K993947 · Siemens Corp.

Substantially Equivalent

510(k) numberK993947

Submission

Device name: Koordinant Angiographic and Operating Room Model X-Ray Table Family
Applicant: Siemens Corp.
Iselin, NJ, US
Received: November 22, 1999
Decision date: December 21, 1999
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

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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Questions and answers

When was Koordinant Angiographic and Operating Room Model X-Ray Table Family cleared by the FDA?

Koordinant Angiographic and Operating Room Model X-Ray Table Family (K993947) received a 510(k) decision of Substantially Equivalent on December 21, 1999, 29 days after the submission was received.

What is the product code of K993947?

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