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FDA 510(k)

BREAS VIVO 40 SYSTEM

K-Number: K053607 · 2006-03-16

ApplicantBreas Medical AB
Decision Date2006-03-16
Product CodeMNT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

BREAS VIVO 40 SYSTEM 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 2006-03-16 under 510(k) number K053607. 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 BREAS VIVO 40 SYSTEM?

BREAS VIVO 40 SYSTEM is a medical device that received FDA 510(k) clearance on 2006-03-16. The listed applicant is Breas Medical AB. The 510(k) number is K053607.

When did BREAS VIVO 40 SYSTEM receive FDA 510(k) clearance?

BREAS VIVO 40 SYSTEM received FDA 510(k) clearance on 2006-03-16, under 510(k) number K053607.

Who is the listed applicant for BREAS VIVO 40 SYSTEM?

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 BREAS VIVO 40 SYSTEM?

The FDA product code for BREAS VIVO 40 SYSTEM is MNT.

Related Clinical Trials

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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 LSK240779Vivo 3K240778Vivo 1, Vivo 2K193586Vivo 45 LS

View all 15 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.K240779Vivo 3Breas Medical ABK233643F&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.

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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