FDA 510(k)

VIVO 50

K-Number: K123144 · 2013-06-18

ApplicantGe Healthcare, Breas Medical AB

Decision Date2013-06-18

Product CodeNOU

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

VIVO 50 is the device name listed in this FDA 510(k) record. The listed applicant is Ge Healthcare, Breas Medical AB. It received FDA 510(k) clearance on 2013-06-18 under 510(k) number K123144. 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 50?

VIVO 50 is a medical device that received FDA 510(k) clearance on 2013-06-18. The listed applicant is Ge Healthcare, Breas Medical AB. The 510(k) number is K123144.

When did VIVO 50 receive FDA 510(k) clearance?

VIVO 50 received FDA 510(k) clearance on 2013-06-18, under 510(k) number K123144.

Who is the listed applicant for VIVO 50?

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

What is the FDA product code for VIVO 50?

The FDA product code for VIVO 50 is NOU.

Related Devices (Code: NOU)

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.

K233452Vivo 45 LSBreas Medical AB K193586Vivo 45 LSBreas Medical AB K160481Vivo 60Breas Medical AB K034032PLV CONTINUUM VENTILATOR, MODEL P2000Respironics California, Inc.K022750PLV CONTINUUM VENTILATOR, MODEL P1000Respironics California, Inc.K021981IVENT 201 PORTABLE VENTILATORVersamed , Ltd.

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.