BZC · Calculator, Pulmonary Function Data
Anesthesiology · 21 CFR 868.1880 · Class 2
Overview
| Product Code | BZC |
|---|---|
| Device Name | Calculator, Pulmonary Function Data |
| Regulation | 21 CFR 868.1880 |
| Device Class | Class 2 |
| Review Panel | Anesthesiology |
| 3rd-Party Reviewable | Yes |
Identification
A pulmonary-function data calculator is a device used to calculate pulmonary-function values based on actual physical data obtained during pulmonary-function testing.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 90)
Showing 20 most recent of 90 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K240293 | STS | Techbopulm, Ltd. | Sep 17, 2024 | SESE |
| K183567 | Vyntus/SentrySuite Product Line | Vyaire Medical | Aug 23, 2019 | SESE |
| K190853 | Vyntus BODY | Vyaire Medical, Inc. | Aug 16, 2019 | SESE |
| K181524 | Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable CART, Vyntus ONE PFT only with adjustable CART | Vyaire Medical, Inc. | Nov 30, 2018 | SESE |
| K162515 | COSMED K5 Wearable Metabolic Technology | Cosmed Srl | Jun 20, 2017 | SESE |
| K161295 | MiniBox + | Pulmone Advanced Medical Devices, Ltd. | Oct 21, 2016 | SESE |
| K150810 | Vyntus / SentrySuite Product Line | Carefusion Germany 234 GmbH | Aug 14, 2015 | SESE |
| K133925 | VYNTUS/ SENTRYSUITE PRODUCT LINE | Carefusion Germany 234 GmbH | Aug 22, 2014 | SESE |
| K133051 | PULMONE MINIBOX PFT TM | Pulmone Advanced Medical Devices, Ltd. | May 2, 2014 | SESE |
| K102047 | LCI OPTION FOR INNOCOR | Innovision A/S | Nov 1, 2011 | SESE |
| K072323 | MASTERSCREEN & OXYCON CPX | Viasys Healthcare GmbH | Oct 10, 2007 | SESE |
| K052328 | ZAN LUNG-FUNCTION LAB | Zan Messgerate GmbH | Dec 22, 2005 | SESE |
| K040698 | MASTERSCREEN CPX AND OXYCON CPX | Viasys Healthcare GmbH | Apr 7, 2004 | SESE |
| K023120 | OXYCON MOBILE | Erich Jaeger GmbH | Nov 12, 2003 | SESE |
| K011344 | INFANT PLETHYSMOGRAPH, MODEL 004400; PEDIATRIC PLETHYSMOGRAPH, MODEL 004400 | Collins Medical, Inc. | May 17, 2002 | SESE |
| K001631 | CORTEX METAMAX | Cortex Biophysik GmbH | Feb 22, 2001 | SESE |
| K001174 | COSMED QUARK | Cosmed Srl | Jan 11, 2001 | SESE |
| K001502 | AEROSOL PROVOCATION SYSTEM APS PRO, MODEL APS PRO | Erich Jaeger GmbH | Jul 12, 2000 | SESE |
| K992214 | OXYCON PRO | Erich Jaeger B.V. | Feb 22, 2000 | SESE |
| K982499 | COSMO PLUS WITH NICO, MODEL 8200 | Novametrix Medical Systems, Inc. | Oct 16, 1998 | SESE |
Top Applicants
- Erich Jaeger, Inc. — 5 clearances
- Novametrix Medical Systems, Inc. — 4 clearances
- Warren E. Collins, Inc. — 4 clearances
- Cardio Pulmonary Instruments — 3 clearances
- Cosmed Srl — 3 clearances
