Targogrid

FDA 510(k) K970037 · Daum GmbH

Substantially Equivalent

510(k) numberK970037

Submission

Device name
Targogrid
Applicant
Daum GmbH
Schwerin, DE
Received
January 6, 1997
Decision date
March 12, 1997
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
LNH – System, Nuclear Magnetic Resonance Imaging
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1000
Specialty
Radiology

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Questions and answers

When was Targogrid cleared by the FDA?

Targogrid (K970037) received a 510(k) decision of Substantially Equivalent on March 12, 1997, 65 days after the submission was received.

What is the product code of K970037?

The FDA product code is LNH – System, Nuclear Magnetic Resonance Imaging, a Class II (moderate risk) device regulated under 21 CFR 892.1000.