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510(k) K192584

BEACON Caresystem Model 00002144 by Mermaid Care A/S — Product Code BZK

K192584 is an FDA 510(k) premarket notification submitted by Mermaid Care A/S for the device "BEACON Caresystem Model 00002144". The FDA issued a decision of Substantially Equivalent on December 18, 2019. The device falls under product code BZK (Spirometer, Monitoring (W/Wo Alarm)), a Class II device regulated under 21 CFR 868.1850.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 2019
Date Received
September 19, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Spirometer, Monitoring (W/Wo Alarm)
Device Class
Class II
Regulation Number
868.1850
Review Panel
AN
Submission Type

Other clearances for product code BZK

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  • K180788 — Gas Module 3 (October 24, 2018)
  • K173181 — ExSpiron 1Xi (March 16, 2018)
  • K162131 — ExSpiron 1Xi (May 9, 2017)
  • K130170 — EXSPIRON 1XI (May 29, 2013)
  • K120087 — EXSPIRON (September 26, 2012)
  • K103578 — PHILIPS NM3 RESPIRATORY MONITOR WITH VENTASSIST (June 2, 2011)
  • K091853 — WRIGHT RESPIROMETER, MARK 8, AND 14 RESPIROMETER, MODEL 700-021, 700-008, 700-01 (September 21, 2009)
  • K092217 — MERCURY VCO2 (August 21, 2009)
  • K091459 — PHILIPS NM3 MONITOR, MODEL 7900 (July 28, 2009)

FDA data resources