FDA 510(k)

Vivo 45 LS

K-Number: K193586 · 2021-01-27

Decision Date2021-01-27

Product CodeNOU

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

Vivo 45 LS is the device name listed in this FDA 510(k) record. The listed applicant is Breas Medical AB. It received FDA 510(k) clearance on 2021-01-27 under 510(k) number K193586. The device is classified under product code NOU. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Vivo 45 LS?

Vivo 45 LS is a medical device that received FDA 510(k) clearance on 2021-01-27. The listed applicant is Breas Medical AB. The 510(k) number is K193586.

When did Vivo 45 LS receive FDA 510(k) clearance?

Vivo 45 LS received FDA 510(k) clearance on 2021-01-27, under 510(k) number K193586.

Who is the listed applicant for Vivo 45 LS?

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

What is the FDA product code for Vivo 45 LS?

The FDA product code for Vivo 45 LS is NOU.

Other records listing Breas Medical AB 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.

K242485EveryWare K242438Clearo K233452Vivo 45 LS K240779Vivo 3 K240778Vivo 1, Vivo 2 K160481Vivo 60

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Related Devices (Code: NOU)

K233452Vivo 45 LSBreas Medical AB K160481Vivo 60Breas Medical AB

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.