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FDA 510(k)

NEUROMAP

K-Number: K981820 · 1998-11-20

ApplicantRadionics, Inc.
Decision Date1998-11-20
Product CodeGZL
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NEUROMAP is the device name listed in this FDA 510(k) record. The listed applicant is Radionics, Inc.. It received FDA 510(k) clearance on 1998-11-20 under 510(k) number K981820. The device is classified under product code GZL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEUROMAP?

NEUROMAP is a medical device that received FDA 510(k) clearance on 1998-11-20. The listed applicant is Radionics, Inc.. The 510(k) number is K981820.

When did NEUROMAP receive FDA 510(k) clearance?

NEUROMAP received FDA 510(k) clearance on 1998-11-20, under 510(k) number K981820.

Who is the listed applicant for NEUROMAP?

The FDA 510(k) record lists Radionics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NEUROMAP?

The FDA product code for NEUROMAP is GZL.

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Other records listing Radionics, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K030697RADIONICS SINGLE USE GROUND PAD (DGP-HP)K002773NEUROMAP WITH NEURO 100K001741RADIONICS RF DISC CATHETER ELECTRODE SYSTEMK992226XDS EXTERNAL CSF DRAINAGE AND MONITORING SYSTEMK001950OPTICAL TRACKING SYSTEM (OTS)K001700XPLAN 2.1

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Related Devices (Code: GZL)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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