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FDA 510(k)

BEACON Caresystem Model 00002144

K-Number: K192584 · 2019-12-18

ApplicantMermaid Care A/S
Decision Date2019-12-18
Product CodeBZK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

BEACON Caresystem Model 00002144 is a medical device manufactured by Mermaid Care A/S. It received FDA 510(k) clearance on 2019-12-18 under approval 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. It is manufactured by Mermaid Care A/S. The 510(k) number is K192584.

When was BEACON Caresystem Model 00002144 approved by the FDA?

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

What company makes BEACON Caresystem Model 00002144?

BEACON Caresystem Model 00002144 is manufactured by Mermaid Care A/S.

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

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

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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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