BZK · Spirometer, Monitoring (W/Wo Alarm)
Anesthesiology · 21 CFR 868.1850 · Class 2
Overview
| Product Code | BZK |
|---|---|
| Device Name | Spirometer, Monitoring (W/Wo Alarm) |
| Regulation | 21 CFR 868.1850 |
| Device Class | Class 2 |
| Review Panel | Anesthesiology |
| 3rd-Party Reviewable | Yes |
Identification
A monitoring spirometer is a device used to measure continuously a patient's tidal volume (volume of gas inhaled by the patient during each respiration cycle) or minute volume (the tidal volume multiplied by the rate of respiration for 1 minute) for the evaluation of the patient's ventilatory status.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 61)
Showing 20 most recent of 61 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K192584 | BEACON Caresystem Model 00002144 | Mermaid Care A/S | Dec 18, 2019 | SESE |
| K192595 | ExSpiron 2Xi | Respiratory Motion | Dec 17, 2019 | SESE |
| K180788 | Gas Module 3 | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | Oct 24, 2018 | SESE |
| K173181 | ExSpiron 1Xi | Respiratory Motion, Inc. | Mar 16, 2018 | SESE |
| K162131 | ExSpiron 1Xi | Respiratory Motion, Inc. | May 9, 2017 | SESE |
| K130170 | EXSPIRON 1XI | Respiratory Motion, Inc. | May 29, 2013 | SESE |
| K120087 | EXSPIRON | Respiratory Motion, Inc. | Sep 26, 2012 | SESE |
| K103578 | PHILIPS NM3 RESPIRATORY MONITOR WITH VENTASSIST | Respironics Novametrix, LLC | Jun 2, 2011 | SESE |
| K091853 | WRIGHT RESPIROMETER, MARK 8, AND 14 RESPIROMETER, MODEL 700-021, 700-008, 700-014 | Nspire Health, Inc. | Sep 21, 2009 | SESE |
| K092217 | MERCURY VCO2 | Respironics Novametrix, Inc. | Aug 21, 2009 | SESE |
| K091459 | PHILIPS NM3 MONITOR, MODEL 7900 | Respironics Novametrix, LLC | Jul 28, 2009 | SESE |
| K080652 | MERCURY VCO2 MODULE WITH CAPNOSTAT 5 | Respironics Novametrix, LLC | Jun 20, 2008 | SESE |
| K062754 | GAS MODULE SE, MODEL 0998-00-0481-02 | Datascope Corp. | Nov 2, 2006 | SESE |
| K051279 | CALDYNE, INC. EXHALOMETER EX100, MODEL EX100 | Caldyne, Inc. | Sep 7, 2005 | SESE |
| K983274 | STARTRACK INFANT GRAPHICS MONITOR | Nellcor Puritan Bennett, Inc. | Dec 9, 1998 | SESE |
| K972086 | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS311 | Alexander Mfg. Co. | Aug 12, 1997 | SESE |
| K932098 | CAPNOMAC ULTIMA ANESTHESIA MONITOR | Datex Division Instrumentarium Corp. | Nov 29, 1993 | SESE |
| K931542 | NEWPORT COMPASS EXHALED TIDAL VOLUME MONITOR | Newport Medical Instruments, Inc. | Oct 25, 1993 | SESE |
| K921717 | BICORE SMARTVALVE OCCLUSION VALVE | Bicore Monitoring Systems | Nov 6, 1992 | SESE |
| K903674 | MODEL 295 ELECTRONIC RESPIROMETER | National Medical Sales, Inc. | Jan 4, 1991 | SESE |
Top Applicants
- Respitrace Corp. — 6 clearances
- Bear Medical Systems, Inc. — 4 clearances
- Ohmeda Medical — 4 clearances
- Respiratory Motion, Inc. — 4 clearances
- Boehringer Laboratories — 3 clearances
