Cleared Traditional

BEACON Caresystem Model 00002144

K192584 · Mermaid Care A/S · Anesthesiology
Dec 2019
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K192584 is an FDA 510(k) clearance for the BEACON Caresystem Model 00002144, a Spirometer, Monitoring (w/wo Alarm) (Class II — Special Controls, product code BZK), submitted by Mermaid Care A/S (Norresundby, DK). The FDA issued a Cleared decision on December 18, 2019, 90 days after receiving the submission on September 19, 2019. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1850.

Submission Details

510(k) Number K192584 FDA.gov
FDA Decision Cleared SESE
Date Received September 19, 2019
Decision Date December 18, 2019
Days to Decision 90 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BZK — Spirometer, Monitoring (w/wo Alarm)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.1850