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FDA 510(k)

TRABECTOME HIGH FREQUENCY GENERATOR/LP

K-Number: K061258 · 2006-05-18

ApplicantNeomedix Corp.
Decision Date2006-05-18
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TRABECTOME HIGH FREQUENCY GENERATOR/LP is the device name listed in this FDA 510(k) record. The listed applicant is Neomedix Corp.. It received FDA 510(k) clearance on 2006-05-18 under 510(k) number K061258. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRABECTOME HIGH FREQUENCY GENERATOR/LP?

TRABECTOME HIGH FREQUENCY GENERATOR/LP is a medical device that received FDA 510(k) clearance on 2006-05-18. The listed applicant is Neomedix Corp.. The 510(k) number is K061258.

When did TRABECTOME HIGH FREQUENCY GENERATOR/LP receive FDA 510(k) clearance?

TRABECTOME HIGH FREQUENCY GENERATOR/LP received FDA 510(k) clearance on 2006-05-18, under 510(k) number K061258.

Who is the listed applicant for TRABECTOME HIGH FREQUENCY GENERATOR/LP?

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

What is the FDA product code for TRABECTOME HIGH FREQUENCY GENERATOR/LP?

The FDA product code for TRABECTOME HIGH FREQUENCY GENERATOR/LP is GEI.

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Other records listing Neomedix Corp. 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.

K040584NMX-1000K040239SUPRAFLOW CONSOLEK024304MICROSURGICAL BIPOLAR HANDPIECE

Related Devices (Code: GEI)

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Official Source

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

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