FDA 510(k)

Vitalograph Model 2120 In2itive eDiary

K-Number: K200550 · 2020-07-27

Decision Date2020-07-27

Product CodeBZG

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

Vitalograph Model 2120 In2itive eDiary 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 2020-07-27 under 510(k) number K200550. 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 2120 In2itive eDiary?

Vitalograph Model 2120 In2itive eDiary is a medical device that received FDA 510(k) clearance on 2020-07-27. The listed applicant is Vitalograph Ireland, Ltd.. The 510(k) number is K200550.

When did Vitalograph Model 2120 In2itive eDiary receive FDA 510(k) clearance?

Vitalograph Model 2120 In2itive eDiary received FDA 510(k) clearance on 2020-07-27, under 510(k) number K200550.

Who is the listed applicant for Vitalograph Model 2120 In2itive eDiary?

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 2120 In2itive eDiary?

The FDA product code for Vitalograph Model 2120 In2itive eDiary 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.