Product code CBQ
- Device name
- Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)
- Medical specialty
- Anesthesiology
- Device class
- 2
- Regulation number
- 868.1500
- 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 |
|---|---|---|---|
| K040917 | PHILIPS ANESTHESIA GAS MONITOR, MODEL M1026B | Philips Medizin Systeme Boeblingen GmbH | 2004-04-29 |
| K994188 | MODIFICATION TO AGILENT TECHNOLOGIES ANESTHESIA GAS MONITOR, MODEL M1026A #CO5 | Agilent Technologies, GmbH | 2000-05-19 |
| K962648 | OHMEDA MODEL 5330 ANESTHETIC AGENT MONITOR | Ohmeda Medical | 1997-01-17 |
| K931439 | OHMEDA MODEL 5330 ANESTHETIC MONITOR | Ohmeda Medical | 1993-10-19 |
| K926451 | DATASCOPE MULTINEX II | Datascope Corp. | 1993-08-25 |
| K923433 | AS/3 ANAESTHESIA MONITORING SYSTEM AIRWAY MODULE | Instrumentarium Corp. | 1993-07-22 |
| K923276 | CAPNOMAC ULTIMA ANESTHESIA MONITOR | Datex Division Instrumentarium Corp. | 1993-07-21 |
| K922876 | AS/3 COP MODULE | Datex Division Instrumentarium Corp. | 1993-07-21 |
| K930303 | DATASCOPE MULTINEX ID PLUS | Datascope Corp. | 1993-06-16 |
| K914295 | ANESTHETIC GAS MONITOR TYPE 1304, MODIFIED | Bruel & Kjaer | 1992-04-10 |
| K911644 | NGM FRAME | Datex Division Instrumentarium Corp. | 1992-03-04 |
| K911647 | NGM GAS MODULE | Datex Division Instrumentarium Corp. | 1991-09-19 |
| K903104 | CAPNOMAC ULTIMA (TM) ANESTHESIA MONITOR | Datex Division Instrumentarium Corp. | 1991-01-23 |
| K902021 | RASCAL II RESPIRATORY AND ANESTHETIC GAS MONITOR | Albion Instruments | 1990-10-09 |
| K892854 | ANESTHETIC AGENT MONITOR | Criticare Systems, Inc. | 1989-10-13 |
| K892646 | BIOCHEM 8100 ANESTHETIC AGENT MONITOR | Biochem International, Inc. | 1989-08-31 |
| K890606 | OHMEDA 5330 AGENT MONITOR | Ohmeda Medical | 1989-04-20 |
| K883532 | ICOR AGENT MONITOR | Icor AB | 1988-11-04 |
| K881264 | PERMA PURE NAFION TUBE DRYER-MODEL ME | Perma Pure Products, Inc. | 1988-10-25 |
| K863248 | PB GRAPHICS PRINTER AND PB VIDEO DISPLAY | Datex Division Instrumentarium Corp. | 1986-09-03 |
| K861397 | OHMEDA 5300 ANESTHETIC AGENT MONITOR | Ohmeda Medical | 1986-05-29 |
| K861474 | PB253 TO PB254 IR - SPECTROMETER UPGRADE KIT | Datex Division Instrumentarium Corp. | 1986-05-02 |
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|---|---|---|---|
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| B510PMMAX15 | ADVANCED PATIENT MONITOR | ADVANCED INSTRUMENTATIONS, INC. | 2024-12-19 |
| 90840106905075 | PERMA PURE | PERMA PURE LLC | 2024-11-12 |
| 00810020360578 | PERMA PURE | PERMA PURE LLC | 2024-11-06 |
| 00810020360141 | PERMA PURE | PERMA PURE LLC | 2024-11-06 |
| 00810020360516 | PERMA PURE | PERMA PURE LLC | 2024-11-05 |
| 00810020360233 | PERMA PURE | PERMA PURE LLC | 2024-11-05 |
| 00810020360189 | PERMA PURE | PERMA PURE LLC | 2024-11-05 |
| 00810020360080 | PERMA PURE | PERMA PURE LLC | 2024-10-15 |
| 00810020360608 | PERMA PURE | PERMA PURE LLC | 2024-10-15 |
| 00810020360417 | PERMA PURE | PERMA PURE LLC | 2024-10-15 |
| 00810020360370 | PERMA PURE | PERMA PURE LLC | 2024-10-15 |
| 90840106905235 | PERMA PURE | PERMA PURE LLC | 2024-10-15 |
| 00810020360295 | PERMA PURE | PERMA PURE LLC | 2024-10-15 |
| 10841522108846 | Ultraview | SPACELABS HEALTHCARE (WASHINGTON), INC | 2024-05-13 |
| 00195278522313 | CARESCAPE Canvas Smart Display | GE Healthcare Finland Oy | 2023-04-19 |
| 00195278524089 | NA | GE Healthcare Finland Oy | 2023-04-19 |
| 00195278523365 | CARESCAPE Canvas D19 | GE Healthcare Finland Oy | 2023-04-19 |
| 00195278522320 | CARESCAPE Canvas 1000 | GE Healthcare Finland Oy | 2023-04-19 |
| B510PM2000XLPRO1 | ADVANCED PATIENT MONITOR | ADVANCED INSTRUMENTATIONS, INC. | 2020-04-16 |
| B510PM2000XLPLUS1 | ADVANCED PATIENT MONITOR | ADVANCED INSTRUMENTATIONS, INC. | 2020-04-16 |
| B510PM2000XL1 | ADVANCED PATIENT MONITOR | ADVANCED INSTRUMENTATIONS, INC. | 2020-04-16 |
| B510PM2000M1 | ADVANCED PATIENT MONITOR | ADVANCED INSTRUMENTATIONS, INC. | 2020-04-16 |
| 18904269452886 | STAR 65 | SKANRAY TECHNOLOGIES LIMITED | 2019-01-21 |
| 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 |
| 00815871021012 | Waveline EZ-MAX | Avante | 2016-09-23 |
| 17350046131603 | IRMA Airway Adapter | MASIMO CORPORATION | 2016-08-11 |
| 17350046131597 | IRMA™ Airway Adapter | MASIMO CORPORATION | 2016-08-11 |