BZK — Spirometer, Monitoring (W/Wo Alarm) Class II

FDA Device Classification

Classification Details

Product Code
BZK
Device Class
Class II
Regulation Number
868.1850
Submission Type
Review Panel
AN
Medical Specialty
Anesthesiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K192584mermaid careBEACON Caresystem Model 00002144December 18, 2019
K192595respiratory motionExSpiron 2XiDecember 17, 2019
K180788shenzhen mindray bio-medical electronics coGas Module 3October 24, 2018
K173181respiratory motionExSpiron 1XiMarch 16, 2018
K162131respiratory motionExSpiron 1XiMay 9, 2017
K130170respiratory motionEXSPIRON 1XIMay 29, 2013
K120087respiratory motionEXSPIRONSeptember 26, 2012
K103578respironics novametrixPHILIPS NM3 RESPIRATORY MONITOR WITH VENTASSISTJune 2, 2011
K091853nspire healthWRIGHT RESPIROMETER, MARK 8, AND 14 RESPIROMETER, MODEL 700-021, 700-008, 700-01September 21, 2009
K092217respironics novametrixMERCURY VCO2August 21, 2009
K091459respironics novametrixPHILIPS NM3 MONITOR, MODEL 7900July 28, 2009
K080652respironics novametrixMERCURY VCO2 MODULE WITH CAPNOSTAT 5June 20, 2008
K062754datascopeGAS MODULE SE, MODEL 0998-00-0481-02November 2, 2006
K051279caldyneCALDYNE, INC. EXHALOMETER EX100, MODEL EX100September 7, 2005
K983274nellcor puritan bennettSTARTRACK INFANT GRAPHICS MONITORDecember 9, 1998
K972086alexander mfgALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS311August 12, 1997
K932098datex division instrumentariumCAPNOMAC ULTIMA ANESTHESIA MONITORNovember 29, 1993
K931542newport medical instrumentsNEWPORT COMPASS EXHALED TIDAL VOLUME MONITOROctober 25, 1993
K921717bicore monitoring systemsBICORE SMARTVALVE OCCLUSION VALVENovember 6, 1992
K903674national medical salesMODEL 295 ELECTRONIC RESPIROMETERJanuary 4, 1991