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FDA 510(k)

Vivo 3

K-Number: K240779 · 2024-12-13

ApplicantBreas Medical AB
Decision Date2024-12-13
Product CodeMNT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Vivo 3 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 2024-12-13 under 510(k) number K240779. The device is classified under product code MNT. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Vivo 3?

Vivo 3 is a medical device that received FDA 510(k) clearance on 2024-12-13. The listed applicant is Breas Medical AB. The 510(k) number is K240779.

When did Vivo 3 receive FDA 510(k) clearance?

Vivo 3 received FDA 510(k) clearance on 2024-12-13, under 510(k) number K240779.

Who is the listed applicant for Vivo 3?

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 3?

The FDA product code for Vivo 3 is MNT.

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.

K242485EveryWareK242438ClearoK233452Vivo 45 LSK240778Vivo 1, Vivo 2K193586Vivo 45 LSK160481Vivo 60

View all 7 devices →

Related Devices (Code: MNT)

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.

K252182SV70 Ventilator (SV70)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.K242931HFT750UMekics Co., Ltd.K233643F&P Airvo 3 NIV (PT311US)Fisher & Paykel Healthcare, Ltd.K230173Servo-air Lite Ventilator SystemMaquet Critical Care ABK213521Nihon Kohden NKV-330 Ventilator SystemNihon Kohden Orangemed, Inc.K191624F&P Nivairo RT047 Vented Hospital Full Face Mask, Anti-Asphyxiation Valve VersionFisher & Paykel Healthcare Limited

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.

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