FDA 510(k)

Vitalograph Model 6000 Alpha

K-Number: K212938 · 2022-01-26

Decision Date2022-01-26

Product CodeBZG

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

Vitalograph Model 6000 Alpha is the device name listed in this FDA 510(k) record. The listed applicant is Vitalograph Ireland, Ltd.. It received FDA 510(k) clearance on 2022-01-26 under 510(k) number K212938. The device is classified under product code BZG. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Vitalograph Model 6000 Alpha?

Vitalograph Model 6000 Alpha is a medical device that received FDA 510(k) clearance on 2022-01-26. The listed applicant is Vitalograph Ireland, Ltd.. The 510(k) number is K212938.

When did Vitalograph Model 6000 Alpha receive FDA 510(k) clearance?

Vitalograph Model 6000 Alpha received FDA 510(k) clearance on 2022-01-26, under 510(k) number K212938.

Who is the listed applicant for Vitalograph Model 6000 Alpha?

The FDA 510(k) record lists Vitalograph Ireland, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Vitalograph Model 6000 Alpha?

The FDA product code for Vitalograph Model 6000 Alpha is BZG.

Other records listing Vitalograph Ireland, Ltd. 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.

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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.