Product code BZK
- Device name
- Spirometer, Monitoring (W/Wo Alarm)
- Medical specialty
- Anesthesiology
- Device class
- 2
- Regulation number
- 868.1850
- Review panel
- AN
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K192584 | BEACON Caresystem Model 00002144 | Mermaid Care A/S | 2019-12-18 |
| K192595 | ExSpiron 2Xi | Respiratory Motion | 2019-12-17 |
| K180788 | Gas Module 3 | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2018-10-24 |
| K173181 | ExSpiron 1Xi | Respiratory Motion, Inc. | 2018-03-16 |
| K162131 | ExSpiron 1Xi | Respiratory Motion, Inc. | 2017-05-09 |
| K130170 | EXSPIRON 1XI | Respiratory Motion, Inc. | 2013-05-29 |
| K120087 | EXSPIRON | Respiratory Motion, Inc. | 2012-09-26 |
| K103578 | PHILIPS NM3 RESPIRATORY MONITOR WITH VENTASSIST | Respironics Novametrix, LLC | 2011-06-02 |
| K091853 | WRIGHT RESPIROMETER, MARK 8, AND 14 RESPIROMETER, MODEL 700-021, 700-008, 700-014 | Nspire Health, Inc. | 2009-09-21 |
| K092217 | MERCURY VCO2 | Respironics Novametrix, Inc. | 2009-08-21 |
| K091459 | PHILIPS NM3 MONITOR, MODEL 7900 | Respironics Novametrix, LLC | 2009-07-28 |
| K080652 | MERCURY VCO2 MODULE WITH CAPNOSTAT 5 | Respironics Novametrix, LLC | 2008-06-20 |
| K062754 | GAS MODULE SE, MODEL 0998-00-0481-02 | Datascope Corp. | 2006-11-02 |
| K051279 | CALDYNE, INC. EXHALOMETER EX100, MODEL EX100 | Caldyne, Inc. | 2005-09-07 |
| K983274 | STARTRACK INFANT GRAPHICS MONITOR | Nellcor Puritan Bennett, Inc. | 1998-12-09 |
| K972086 | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS311 | Alexander Mfg. Co. | 1997-08-12 |
| K932098 | CAPNOMAC ULTIMA ANESTHESIA MONITOR | Datex Division Instrumentarium Corp. | 1993-11-29 |
| K931542 | NEWPORT COMPASS EXHALED TIDAL VOLUME MONITOR | Newport Medical Instruments, Inc. | 1993-10-25 |
| K921717 | BICORE SMARTVALVE OCCLUSION VALVE | Bicore Monitoring Systems | 1992-11-06 |
| K903674 | MODEL 295 ELECTRONIC RESPIROMETER | National Medical Sales, Inc. | 1991-01-04 |
| K903959 | NEONATAL METASCOPE | Cybermedic, Inc. | 1990-11-23 |
| K901885 | PARTNER VOLUME MONITOR | Bird Products Corp. | 1990-09-27 |
| K890932 | CAV 3.0C SOFTWARE PROGRAM | Siemens Life Support Systems | 1989-06-12 |
| K884910 | MODEL 1010, CY-MET | Cybermedic, Inc. | 1989-06-12 |
| K884959 | RESPITRAK | Non-Invasive Monitoring Systems, Inc. | 1989-06-08 |
| K884942 | MONAGHAN RVM, MODEL 761 | Monaghan Medical Corp. | 1989-06-07 |
| K890724 | MOFIFICATION BEAR NVM-1 NEONATAL VOLUME MONITOR | Bear Medical Systems, Inc. | 1989-03-30 |
| K872660 | BEAR NVM-1 | Bear Medical Systems, Inc. | 1988-02-12 |
| K864886 | RESPIGRAPH-RESPISOMNOGRAPH-RESPICENTRAL | Nims/Respitrace Corp. | 1987-03-06 |
| K863866 | RESPIRADYNE II(TM) | Chesebrough-Pond'S U.S.A. Co. | 1987-01-28 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00195278522313 | CARESCAPE Canvas Smart Display | GE Healthcare Finland Oy | 2023-04-19 |
| 00195278522320 | CARESCAPE Canvas 1000 | GE Healthcare Finland Oy | 2023-04-19 |
| 00195278523365 | CARESCAPE Canvas D19 | GE Healthcare Finland Oy | 2023-04-19 |
| 00195278524089 | NA | GE Healthcare Finland Oy | 2023-04-19 |
| 00840682104135 | NA | GE Healthcare Finland Oy | 2022-03-07 |
| 00840682103602 | NA | GE Healthcare Finland Oy | 2016-08-15 |
| 00840682103886 | NA | GE Healthcare Finland Oy | 2016-08-15 |
| 00840682103701 | NA | GE Healthcare Finland Oy | 2016-08-15 |
| 00840682103671 | NA | GE Healthcare Finland Oy | 2016-08-15 |
| 00840682103664 | NA | GE Healthcare Finland Oy | 2016-08-15 |
| 00840682103626 | NA | GE Healthcare Finland Oy | 2016-08-15 |
| 00840682103619 | NA | GE Healthcare Finland Oy | 2016-08-15 |
| 00840682102810 | NA | GE Healthcare Finland Oy | 2016-08-15 |
| 00840682102841 | NA | GE Healthcare Finland Oy | 2016-08-15 |
| 00840682102858 | NA | GE Healthcare Finland Oy | 2016-08-15 |
| 00840682102889 | NA | GE Healthcare Finland Oy | 2016-08-15 |
| 00840682102872 | NA | GE Healthcare Finland Oy | 2016-08-15 |
| 00840682102865 | NA | GE Healthcare Finland Oy | 2016-08-15 |
| 00840682102926 | NA | GE Healthcare Finland Oy | 2016-08-12 |
| 00840682103688 | NA | GE Healthcare Finland Oy | 2016-06-16 |
| 00840682103596 | NA | GE Healthcare Finland Oy | 2016-06-16 |
| 00840682102919 | NA | GE Healthcare Finland Oy | 2016-06-16 |
| 00840682102803 | NA | GE Healthcare Finland Oy | 2016-06-16 |
| 00840682103930 | CARESCAPE | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. | 2016-06-03 |
| 00840682103978 | NA | GE Healthcare Finland Oy | 2016-06-03 |
| 00840682103992 | NA | GE Healthcare Finland Oy | 2016-06-03 |
| 00840682104067 | NA | GE Healthcare Finland Oy | 2016-06-03 |
| 00840682104142 | NA | GE Healthcare Finland Oy | 2016-06-03 |
| 00840682104180 | NA | GE Healthcare Finland Oy | 2016-06-03 |
| 24710810111291 | N/A | GALEMED CORPORATION | 2015-10-15 |