Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)
FDA product code CBS · Class II (moderate risk) · 21 CFR 868.1620 · Anesthesiology
17510(k) clearances
0PMA approvals
0recalls
Manufacturers
- Datex Division Instrumentarium Corp. 3
- Lkb Instruments, Inc. 1
- Allied Healthcare Products, Inc. 1
- Traverse Medical Monitors 1
- Draeger Medical, Inc. 1
- Bruel & Kjaer Instruments, Inc. 1
- Hewlett-Packard Co. 1
- Nellcor, Inc. 1
- Biochem International, Inc. 1
- Criticare Systems, Inc. 1
- Marquette Electronics, Inc. 1
- Riken Keiki Co., Ltd. 1
- Datex Medical Instrumentation, Inc. 1
- Pace Tech, Inc. 1
- Datascope Corp. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K974903 | Gas Module II, Model 0998-00-0143CBS · Traditional | Datascope Corp. | 03/13/1998SE |
| K953795 | Vitalmax 4100CBS · Traditional | Pace Tech, Inc. | 07/01/1996SE |
| K960490 | AS/3 Compact Airway Module M-CaiovCBS · Traditional | Datex Medical Instrumentation, Inc. | 05/03/1996SE |
| K951366 | Riken Gas Indicator (3 Models, 1806H, 1802D, IF-18)CBS · Traditional | Riken Keiki Co., Ltd. | 08/02/1995SE |
| K950101 | Rams (Random Access Mass Spectrometer) M-200 Respiratory Gas MonitorCBS · Traditional | Marquette Electronics, Inc. | 03/21/1995SE |
| K943458 | AS/3 Airway ModuleCBS · Traditional | Datex Division Instrumentarium Corp. | 02/14/1995SE |
| K942737 | Poet Iq with Five Agent CapabilityCBS · Traditional | Criticare Systems, Inc. | 02/09/1995SE |
| K932389 | 8100 Anesthetic Agent MonitorCBS · Traditional | Biochem International, Inc. | 12/03/1993SE |
| K905754 | Capnomac Ultima Anesthesia MonitorCBS · Traditional | Datex Division Instrumentarium Corp. | 06/17/1991SE |
| K896629 | Nellcor Model N-2500 Anesthesia Safety MonitorCBS · Traditional | Nellcor, Inc. | 02/12/1990SE |
| K896216 | Hewlett Packard Anesthetic Gas Analyzer M1025ACBS · Traditional | Hewlett-Packard Co. | 01/16/1990SE |
| K890446 | Anesthetic Gas MonitorCBS · Traditional | Bruel & Kjaer Instruments, Inc. | 08/11/1989SE |
| K873194 | Spectramed Respiratory Gas AnalyzerCBS · Traditional | Draeger Medical, Inc. | 10/30/1987SE |
| K863801 | TMM Model 3000 Anesthesia Circuit EvaluatorCBS · Traditional | Traverse Medical Monitors | 01/12/1987SE |
| K832113 | Normac Anesthetic Agent MonitorCBS · Traditional | Datex Division Instrumentarium Corp. | 09/12/1983SE |
| K810585 | SaraCBS · Traditional | Allied Healthcare Products, Inc. | 03/24/1981SE |
| K802614 | Engstrom Emma Anesthetic Gas MonitorCBS · Traditional | Lkb Instruments, Inc. | 01/07/1981SE |