BEACON Caresystem Model 00002144

FDA 510(k) K192584 · Mermaid Care A/S

Substantially Equivalent

510(k) numberK192584

Submission

Device name
BEACON Caresystem Model 00002144
Applicant
Mermaid Care A/S
Norresundby, DK
Received
September 19, 2019
Decision date
December 18, 2019
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
BZK – Spirometer, Monitoring (W/Wo Alarm)
Device class
Class II (moderate risk)
Regulation
21 CFR 868.1850
Specialty
Anesthesiology

Other 510(k)s with product code BZK

510(k)DeviceApplicantDecision
K192595ExSpiron 2XiBZK · Special Respiratory Motion12/17/2019SE
K180788Gas Module 3BZK · Traditional Shenzhen Mindray Bio-Medical Electronics Co., Ltd.10/24/2018SE
K173181ExSpiron 1XiBZK · Traditional Respiratory Motion, Inc.03/16/2018SE
K162131ExSpiron 1XiBZK · Traditional Respiratory Motion, Inc.05/09/2017SE
K130170Exspiron 1XIBZK · Special Respiratory Motion, Inc.05/29/2013SE
K120087ExspironBZK · Traditional Respiratory Motion, Inc.09/26/2012SE
K103578Philips NM3 Respiratory Monitor with VentassistBZK · Traditional Respironics Novametrix, LLC06/02/2011SE
K091853Wright Respirometer, Mark 8, and 14 Respirometer, Model 700-021, 700-008, 700-014BZK · Traditional Nspire Health, Inc.09/21/2009SE
K092217Mercury VCO2BZK · Special Respironics Novametrix, Inc.08/21/2009SE
K091459Philips NM3 Monitor, Model 7900BZK · Special Respironics Novametrix, LLC07/28/2009SE

Questions and answers

When was BEACON Caresystem Model 00002144 cleared by the FDA?

BEACON Caresystem Model 00002144 (K192584) received a 510(k) decision of Substantially Equivalent on December 18, 2019, 90 days after the submission was received.

What is the product code of K192584?

The FDA product code is BZK – Spirometer, Monitoring (W/Wo Alarm), a Class II (moderate risk) device regulated under 21 CFR 868.1850.