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BZC — Calculator, Pulmonary Function Data Class II

FDA Device Classification

FDA product code BZC covers "Calculator, Pulmonary Function Data", a Class II medical device regulated under 21 CFR 868.1880. Submissions are reviewed by the Anesthesiology panel. At least 20 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
BZC
Device Class
Class II
Regulation Number
868.1880
Submission Type
Review Panel
AN
Medical Specialty
Anesthesiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K240293techbopulmSTSSeptember 17, 2024
K183567vyaire medicalVyntus/SentrySuite Product LineAugust 23, 2019
K190853vyaire medicalVyntus BODYAugust 16, 2019
K181524vyaire medicalVyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable November 30, 2018
K162515cosmedCOSMED K5 Wearable Metabolic TechnologyJune 20, 2017
K161295pulmone advanced medical devicesMiniBox +October 21, 2016
K150810carefusion germany 234Vyntus / SentrySuite Product LineAugust 14, 2015
K133925carefusion germany 234VYNTUS/ SENTRYSUITE PRODUCT LINEAugust 22, 2014
K133051pulmone advanced medical devicesPULMONE MINIBOX PFT TMMay 2, 2014
K102047innovisionLCI OPTION FOR INNOCORNovember 1, 2011
K072323viasys healthcareMASTERSCREEN & OXYCON CPXOctober 10, 2007
K052328zan messgerateZAN LUNG-FUNCTION LABDecember 22, 2005
K040698viasys healthcareMASTERSCREEN CPX AND OXYCON CPXApril 7, 2004
K023120erich jaegerOXYCON MOBILENovember 12, 2003
K011344collins medicalINFANT PLETHYSMOGRAPH, MODEL 004400; PEDIATRIC PLETHYSMOGRAPH, MODEL 004400May 17, 2002
K001631cortex biophysikCORTEX METAMAXFebruary 22, 2001
K001174cosmedCOSMED QUARKJanuary 11, 2001
K001502erich jaegerAEROSOL PROVOCATION SYSTEM APS PRO, MODEL APS PROJuly 12, 2000
K992214erich jaegerOXYCON PROFebruary 22, 2000
K982499novametrix medical systemsCOSMO PLUS WITH NICO, MODEL 8200October 16, 1998

FDA data resources