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FDA 510(k)

VOXAR VC, MODEL 1.0

K-Number: K012072 · 2001-07-12

ApplicantVoxar Limited
Decision Date2001-07-12
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

VOXAR VC, MODEL 1.0 is the device name listed in this FDA 510(k) record. The listed applicant is Voxar Limited. It received FDA 510(k) clearance on 2001-07-12 under 510(k) number K012072. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VOXAR VC, MODEL 1.0?

VOXAR VC, MODEL 1.0 is a medical device that received FDA 510(k) clearance on 2001-07-12. The listed applicant is Voxar Limited. The 510(k) number is K012072.

When did VOXAR VC, MODEL 1.0 receive FDA 510(k) clearance?

VOXAR VC, MODEL 1.0 received FDA 510(k) clearance on 2001-07-12, under 510(k) number K012072.

Who is the listed applicant for VOXAR VC, MODEL 1.0?

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

What is the FDA product code for VOXAR VC, MODEL 1.0?

The FDA product code for VOXAR VC, MODEL 1.0 is LLZ.

Related Clinical Trials

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Other records listing Voxar Limited 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.

K043194VOXAR 3D PRODUCT FAMILYK020140VOXAR'S CALCIUM SCORING PRODUCTK992654PLUG 'N VIEW 3D, VERSION 1.0

Related Devices (Code: LLZ)

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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