Product code CBS
- Device name
- Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)
- Medical specialty
- Anesthesiology
- Device class
- 2
- Regulation number
- 868.1620
- 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 |
|---|---|---|---|
| K974903 | GAS MODULE II, MODEL 0998-00-0143 | Datascope Corp. | 1998-03-13 |
| K953795 | VITALMAX 4100 | Pace Tech, Inc. | 1996-07-01 |
| K960490 | AS/3 COMPACT AIRWAY MODULE M-CAIOV | Datex Medical Instrumentation, Inc. | 1996-05-03 |
| K951366 | RIKEN GAS INDICATOR (3 MODELS, 1806H, 1802D, IF-18) | Riken Keiki Co., Ltd. | 1995-08-02 |
| K950101 | RAMS (RANDOM ACCESS MASS SPECTROMETER) M-200 RESPIRATORY GAS MONITOR | Marquette Electronics, Inc. | 1995-03-21 |
| K943458 | AS/3 AIRWAY MODULE | Datex Division Instrumentarium Corp. | 1995-02-14 |
| K942737 | POET IQ WITH FIVE AGENT CAPABILITY | Criticare Systems, Inc. | 1995-02-09 |
| K932389 | 8100 ANESTHETIC AGENT MONITOR | Biochem International, Inc. | 1993-12-03 |
| K905754 | CAPNOMAC ULTIMA ANESTHESIA MONITOR | Datex Division Instrumentarium Corp. | 1991-06-17 |
| K896629 | NELLCOR MODEL N-2500 ANESTHESIA SAFETY MONITOR | Nellcor, Inc. | 1990-02-12 |
| K896216 | HEWLETT PACKARD ANESTHETIC GAS ANALYZER M1025A | Hewlett-Packard Co. | 1990-01-16 |
| K890446 | ANESTHETIC GAS MONITOR | Bruel & Kjaer Instruments, Inc. | 1989-08-11 |
| K873194 | SPECTRAMED RESPIRATORY GAS ANALYZER | Draeger Medical, Inc. | 1987-10-30 |
| K863801 | TMM MODEL 3000 ANESTHESIA CIRCUIT EVALUATOR | Traverse Medical Monitors | 1987-01-12 |
| K832113 | NORMAC ANESTHETIC AGENT MONITOR | Datex Division Instrumentarium Corp. | 1983-09-12 |
| K810585 | SARA | Allied Healthcare Products, Inc. | 1981-03-24 |
| K802614 | ENGSTROM EMMA ANESTHETIC GAS MONITOR | Lkb Instruments, Inc. | 1981-01-07 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| B510PMMAX13 | ADVANCED PATIENT MONITOR | ADVANCED INSTRUMENTATIONS, INC. | 2024-12-19 |
| B510PMMAX15 | ADVANCED PATIENT MONITOR | ADVANCED INSTRUMENTATIONS, INC. | 2024-12-19 |
| 10841522108846 | Ultraview | SPACELABS HEALTHCARE (WASHINGTON), INC | 2024-05-13 |
| 00195278524089 | NA | GE Healthcare Finland Oy | 2023-04-19 |
| 00195278522320 | CARESCAPE Canvas 1000 | GE Healthcare Finland Oy | 2023-04-19 |
| 00195278522313 | CARESCAPE Canvas Smart Display | GE Healthcare Finland Oy | 2023-04-19 |
| B510PM2000M1 | ADVANCED PATIENT MONITOR | ADVANCED INSTRUMENTATIONS, INC. | 2020-04-16 |
| B510PM2000TM1 | ADVANCED PATIENT MONITOR | ADVANCED INSTRUMENTATIONS, INC. | 2020-04-16 |
| B510PM2000XL1 | ADVANCED PATIENT MONITOR | ADVANCED INSTRUMENTATIONS, INC. | 2020-04-16 |
| B510PM2000XLPLUS1 | ADVANCED PATIENT MONITOR | ADVANCED INSTRUMENTATIONS, INC. | 2020-04-16 |
| B510PM2000XLPRO1 | ADVANCED PATIENT MONITOR | ADVANCED INSTRUMENTATIONS, INC. | 2020-04-16 |
| 18904269452886 | STAR 65 | SKANRAY TECHNOLOGIES LIMITED | 2019-01-21 |
| 10841522107825 | Spacelabs Healthcare | SPACELABS HEALTHCARE (WASHINGTON), INC | 2017-04-13 |
| 10841522107818 | UltraviewSL | SPACELABS HEALTHCARE (WASHINGTON), INC | 2017-03-10 |
| 20884838072248 | Spirometry Sensor | Philips Medizin Systeme Böblingen GmbH | 2017-01-20 |
| 10841522113109 | Spacelabs | SPACELABS HEALTHCARE (WASHINGTON), INC | 2016-11-30 |
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