Product code CBR
- Device name
- Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)
- Medical specialty
- Anesthesiology
- Device class
- 2
- Regulation number
- 868.1700
- 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 |
|---|---|---|---|
| K112173 | SPEACELABS MULTIGAS MODULE | Spacelabs Healthcare | 2011-10-05 |
| K053599 | SPACELABS MEDICAL MULTIGAS ANALYZER MODULE 91518 AND ACCESSORIES | Spacelabs Medical, Inc. | 2006-04-19 |
| K954962 | SPACELABS MEDICAL MULTIGAS ANALYZER | Spacelabs, Inc. | 1996-05-31 |
| K904843 | OSCAR(TM) II CAPNOMETER & PULSE OXIMETER | Dalton Instrument Corp. | 1991-04-09 |
| K853360 | N20 TEST | Erich Jaeger, Inc. | 1985-09-03 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| B510PMMAX15 | ADVANCED PATIENT MONITOR | ADVANCED INSTRUMENTATIONS, INC. | 2024-12-19 |
| B510PMMAX13 | ADVANCED PATIENT MONITOR | ADVANCED INSTRUMENTATIONS, INC. | 2024-12-19 |
| 10841522127373 | Trulink | SPACELABS HEALTHCARE (WASHINGTON), INC | 2024-06-07 |
| 10841522108846 | Ultraview | SPACELABS HEALTHCARE (WASHINGTON), INC | 2024-05-13 |
| 10841522127366 | Trulink | SPACELABS HEALTHCARE (WASHINGTON), INC | 2024-04-22 |
| 00195278524089 | NA | GE Healthcare Finland Oy | 2023-04-19 |
| 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 |
| 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 |
| B23133121 | Metaphor Flow Sensor | TREYMED INC | 2017-09-27 |
| B23133131 | Metaphor Flow Sensor | TREYMED INC | 2017-09-27 |
| B23133141 | Metaphor Flow Sensor | TREYMED INC | 2017-09-27 |
| B23133151 | Metaphor Flow Sensor | TREYMED INC | 2017-09-27 |
| 10841522107818 | UltraviewSL | SPACELABS HEALTHCARE (WASHINGTON), INC | 2017-03-10 |
| 10841522107795 | UltraviewSL | SPACELABS HEALTHCARE (WASHINGTON), INC | 2017-03-10 |
| 20884838072248 | Spirometry Sensor | Philips Medizin Systeme Böblingen GmbH | 2017-01-20 |
| 00815871021012 | Waveline EZ-MAX | Avante | 2016-09-23 |
| 00815871021029 | Waveline EZ-MAX | Avante | 2016-09-23 |
| 00815871021036 | Waveline EZ-MAX | Avante | 2016-09-23 |
| 00815871021043 | Waveline EZ-MAX | Avante | 2016-09-23 |
| 00815871021050 | Waveline EZ-MAX | Avante | 2016-09-23 |
| 00815871021081 | Waveline Pro+ | Avante | 2016-09-23 |
| 17350046131603 | IRMA Airway Adapter | MASIMO CORPORATION | 2016-08-11 |
| 17350046131597 | IRMA™ Airway Adapter | MASIMO CORPORATION | 2016-08-11 |