Neuromap

FDA 510(k) K981820 · Radionics, Inc.

Substantially Equivalent

510(k) numberK981820

Submission

Device name
Neuromap
Applicant
Radionics, Inc.
Burlington, MA, US
Received
May 22, 1998
Decision date
November 20, 1998
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
GZL – Electrode, Depth
Device class
Class II (moderate risk)
Regulation
21 CFR 882.1330
Specialty
Neurology

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Questions and answers

When was Neuromap cleared by the FDA?

Neuromap (K981820) received a 510(k) decision of Substantially Equivalent on November 20, 1998, 182 days after the submission was received.

What is the product code of K981820?

The FDA product code is GZL – Electrode, Depth, a Class II (moderate risk) device regulated under 21 CFR 882.1330.