Vitalograph Model 6000 Alpha
K-Number: K212938 · 2022-01-26
ApplicantVitalograph Ireland, Ltd.
Decision Date2022-01-26
Product CodeBZG
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
Vitalograph Model 6000 Alpha is a medical device manufactured by Vitalograph Ireland, Ltd.. It received FDA 510(k) clearance on 2022-01-26 under approval 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. It is manufactured by Vitalograph Ireland, Ltd.. The 510(k) number is K212938.
When was Vitalograph Model 6000 Alpha approved by the FDA?
Vitalograph Model 6000 Alpha received FDA 510(k) clearance on 2022-01-26, under approval number K212938.
What company makes Vitalograph Model 6000 Alpha?
Vitalograph Model 6000 Alpha is manufactured by Vitalograph Ireland, Ltd..
What is the FDA product code for Vitalograph Model 6000 Alpha?
The FDA product code for Vitalograph Model 6000 Alpha is BZG.
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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.