FDA 510(k)

HALOFLEX ENERGY GENERATOR, MODELS 1190A-115A AND 1190A-230A

K-Number: K092487 · 2009-11-10

Decision Date2009-11-10

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

HALOFLEX ENERGY GENERATOR, MODELS 1190A-115A AND 1190A-230A is the device name listed in this FDA 510(k) record. The listed applicant is Barrx Medical, Incorporated. It received FDA 510(k) clearance on 2009-11-10 under 510(k) number K092487. 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 HALOFLEX ENERGY GENERATOR, MODELS 1190A-115A AND 1190A-230A?

HALOFLEX ENERGY GENERATOR, MODELS 1190A-115A AND 1190A-230A is a medical device that received FDA 510(k) clearance on 2009-11-10. The listed applicant is Barrx Medical, Incorporated. The 510(k) number is K092487.

When did HALOFLEX ENERGY GENERATOR, MODELS 1190A-115A AND 1190A-230A receive FDA 510(k) clearance?

HALOFLEX ENERGY GENERATOR, MODELS 1190A-115A AND 1190A-230A received FDA 510(k) clearance on 2009-11-10, under 510(k) number K092487.

Who is the listed applicant for HALOFLEX ENERGY GENERATOR, MODELS 1190A-115A AND 1190A-230A?

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

What is the FDA product code for HALOFLEX ENERGY GENERATOR, MODELS 1190A-115A AND 1190A-230A?

The FDA product code for HALOFLEX ENERGY GENERATOR, MODELS 1190A-115A AND 1190A-230A is 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.