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FDA 510(k)

RADIONICS MICROELECTRODE KIT

K-Number: K991399 · 1999-09-21

ApplicantRadionics, Inc.
Decision Date1999-09-21
Product CodeGXI
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

RADIONICS MICROELECTRODE KIT is the device name listed in this FDA 510(k) record. The listed applicant is Radionics, Inc.. It received FDA 510(k) clearance on 1999-09-21 under 510(k) number K991399. The device is classified under product code GXI. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RADIONICS MICROELECTRODE KIT?

RADIONICS MICROELECTRODE KIT is a medical device that received FDA 510(k) clearance on 1999-09-21. The listed applicant is Radionics, Inc.. The 510(k) number is K991399.

When did RADIONICS MICROELECTRODE KIT receive FDA 510(k) clearance?

RADIONICS MICROELECTRODE KIT received FDA 510(k) clearance on 1999-09-21, under 510(k) number K991399.

Who is the listed applicant for RADIONICS MICROELECTRODE KIT?

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 RADIONICS MICROELECTRODE KIT?

The FDA product code for RADIONICS MICROELECTRODE KIT is GXI.

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Other records listing Radionics, Inc. as applicant

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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: GXI)

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.

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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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