FDA 510(k) Applications for Medical Device Product Code "BZC"
(Calculator, Pulmonary Function Data)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K952542 | ACKRAD LABORATORIES | ACKRAD ESOPHAGEAL BALLOON CATHETER SET | 04/23/1996 |
| K982487 | CARDIOPULMONARY TECHNOLOGIES, INC. | CPT, INC. METEOR HAND HELD RESPIRATORY MECHANICS MONITOR METEOR 100, CPT, INC. METEOR HAND HELD RESPIRATORY MECHANICS MO | 10/14/1998 |
| K150810 | CareFusion Germany 234 GmbH | Vyntus / SentrySuite Product Line | 08/14/2015 |
| K133925 | CAREFUSION GERMANY 234 GMBH | VYNTUS/ SENTRYSUITE PRODUCT LINE | 08/22/2014 |
| K011344 | COLLINS MEDICAL, INC. | INFANT PLETHYSMOGRAPH, MODEL 004400; PEDIATRIC PLETHYSMOGRAPH, MODEL 004400 | 05/17/2002 |
| K001631 | CORTEX BIOPHYSIK GMBH | CORTEX METAMAX | 02/22/2001 |
| K963373 | COSMED S.R.L. | COSMED K4 | 09/10/1997 |
| K162515 | COSMED S.r.l. | COSMED K5 Wearable Metabolic Technology | 06/20/2017 |
| K001174 | COSMED S.R.L. | COSMED QUARK | 01/11/2001 |
| K964939 | CREATIVE BIOMEDICS, INC. | THE PORTABLE FAMILY - MEDI-FACTS DX1 PORTABLE LITE AND DX1 PORTABLE PLUS | 03/06/1997 |
| K992214 | ERICH JAEGER B.V. | OXYCON PRO | 02/22/2000 |
| K001502 | ERICH JAEGER GMBH | AEROSOL PROVOCATION SYSTEM APS PRO, MODEL APS PRO | 07/12/2000 |
| K023120 | ERICH JAEGER GMBH | OXYCON MOBILE | 11/12/2003 |
| K102047 | INNOVISION A/S | LCI OPTION FOR INNOCOR | 11/01/2011 |
| K963380 | NOVAMETRIX MEDICAL SYSTEMS, INC. | CO 2 SMO PLUS | 01/22/1997 |
| K982499 | NOVAMETRIX MEDICAL SYSTEMS, INC. | COSMO PLUS WITH NICO, MODEL 8200 | 10/16/1998 |
| K964360 | NOVAMETRIX MEDICAL SYSTEMS, INC. | VENT(VENTCHECK) HANDHELD RESPIRATORY/MECHANICS MONITOR MODEL 101 | 04/04/1997 |
| K960831 | NOVAMETRIX MEDICAL SYSTEMS, INC. | VENTRAK RMMS 1550 | 05/29/1996 |
| K960121 | P.K. MORGAN LTD. | AUTOLINK BODY PLETHYSMOGRAPH | 01/09/1997 |
| K954730 | P.K. MORGAN LTD. | BENCHMARK TRANSFER TEST | 04/01/1997 |
| K953990 | P.K. MORGAN LTD. | TRANSFLOW TEST | 12/09/1996 |
| K161295 | PULMONE ADVANCED MEDICAL DEVICES, LTD | MiniBox + | 10/21/2016 |
| K133051 | PULMONE ADVANCED MEDICAL DEVICES, LTD | PULMONE MINIBOX PFT TM | 05/02/2014 |
| K970840 | SIMTEC, INC. | INTELLIFLOW RESPIRATORY ANALYZER | 11/26/1997 |
| K072323 | VIASYS HEALTHCARE GMBH | MASTERSCREEN & OXYCON CPX | 10/10/2007 |
| K040698 | VIASYS HEALTHCARE GMBH | MASTERSCREEN CPX AND OXYCON CPX | 04/07/2004 |
| K183567 | Vyaire Medical | Vyntus/SentrySuite Product Line | 08/23/2019 |
| K190853 | Vyaire Medical Inc. | Vyntus BODY | 08/16/2019 |
| K181524 | Vyaire Medical, Inc. | Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable CART, Vyntus ONE PFT only with adjustable CART | 11/30/2018 |
| K052328 | ZAN MESSGERATE GMBH | ZAN LUNG-FUNCTION LAB | 12/22/2005 |
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