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FDA 510(k)

HALO360 ENERGY GENERATOR, MODELS 1100C-115B AND 1100C-230B

K-Number: K082202 · 2008-10-08

ApplicantBarrx Medical, Incorporated
Decision Date2008-10-08
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

HALO360 ENERGY GENERATOR, MODELS 1100C-115B AND 1100C-230B 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 2008-10-08 under 510(k) number K082202. 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 HALO360 ENERGY GENERATOR, MODELS 1100C-115B AND 1100C-230B?

HALO360 ENERGY GENERATOR, MODELS 1100C-115B AND 1100C-230B is a medical device that received FDA 510(k) clearance on 2008-10-08. The listed applicant is Barrx Medical, Incorporated. The 510(k) number is K082202.

When did HALO360 ENERGY GENERATOR, MODELS 1100C-115B AND 1100C-230B receive FDA 510(k) clearance?

HALO360 ENERGY GENERATOR, MODELS 1100C-115B AND 1100C-230B received FDA 510(k) clearance on 2008-10-08, under 510(k) number K082202.

Who is the listed applicant for HALO360 ENERGY GENERATOR, MODELS 1100C-115B AND 1100C-230B?

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 HALO360 ENERGY GENERATOR, MODELS 1100C-115B AND 1100C-230B?

The FDA product code for HALO360 ENERGY GENERATOR, MODELS 1100C-115B AND 1100C-230B is GEI.

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Other records listing Barrx Medical, Incorporated 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.

K093855HALO 360 & SIZING BALLOON, MODEL 3441CK093008HALO ABLATION CATHETER, MODEL 90-9100K092487HALOFLEX ENERGY GENERATOR, MODELS 1190A-115A AND 1190A-230AK083737HALO ABLATION CATHETERK083711MODIFICATION TO: HALO COAGULATION CATHETER, MODELS 32041-18, 32041-20, 32041-22, 32041-25, 32041-28, 32041-31, 32041-34K080557BARRX MODELS HALO360 AND HALO360+ COAGULATION CATHETERS

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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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