FDA 510(k)

BEACON Caresystem Model 00002144

K-Number: K192584 · 2019-12-18

Decision Date2019-12-18

Product CodeBZK

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

BEACON Caresystem Model 00002144 is the device name listed in this FDA 510(k) record. The listed applicant is Mermaid Care A/S. It received FDA 510(k) clearance on 2019-12-18 under 510(k) number K192584. The device is classified under product code BZK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BEACON Caresystem Model 00002144?

BEACON Caresystem Model 00002144 is a medical device that received FDA 510(k) clearance on 2019-12-18. The listed applicant is Mermaid Care A/S. The 510(k) number is K192584.

When did BEACON Caresystem Model 00002144 receive FDA 510(k) clearance?

BEACON Caresystem Model 00002144 received FDA 510(k) clearance on 2019-12-18, under 510(k) number K192584.

Who is the listed applicant for BEACON Caresystem Model 00002144?

The FDA 510(k) record lists Mermaid Care A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BEACON Caresystem Model 00002144?

The FDA product code for BEACON Caresystem Model 00002144 is BZK.

Related Devices (Code: BZK)

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.

K192595ExSpiron 2XiRespiratory Motion K180788Gas Module 3Shenzhen Mindray Bio-Medical Electronics Co., Ltd.K173181ExSpiron 1XiRespiratory Motion, Inc.K162131ExSpiron 1XiRespiratory Motion, Inc.

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.