Product code BSZ
- Device name
- Gas-Machine, Anesthesia
- Medical specialty
- Anesthesiology
- Device class
- 2
- Regulation number
- 868.5160
- Review panel
- AN
- Implant
- N
- Life sustaining/supporting
- Y
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252746 | Atlan (A100); Atlan (A100 XL); Atlan(A350); Atlan (A350 XL) | Drägerwerk AG Co. Kgaa | 2026-05-21 |
| K251352 | Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-700i and related 610i, 620i, 630i series enabled to retrofit RFID features); Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-1, SLS XXX, Multiple Models Pendin... | Codonics.Incorporated | 2025-07-11 |
| K230931 | Atlan | Drägerwerk AG Co. Kgaa | 2023-07-23 |
| K213867 | Carestation 750/750c | Datex-Ohmeda, Inc. | 2023-03-28 |
| K201957 | A8, A9 Anesthesia System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2021-03-26 |
| K191027 | Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia System | Maquet Critical Care AB | 2020-03-18 |
| K171311 | A5 Anesthesia System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2018-01-12 |
| K171292 | A7 Anesthesia System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2018-01-12 |
| K172045 | Aestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7100 Compact, Aespire 100, Aespire 7100, Aespire 7900, Aespire View, Avance, Avance CS2, Aisys, Aisys CS2 | Datex-Ohmeda, Inc. | 2017-11-03 |
| K170872 | Aisys CS2 | Datex-Ohmeda, Inc. | 2017-08-15 |
| K160665 | FLOW-i Anesthesia System C20, FLOW-i Anesthesia System C30, FLOW-i Anesthesia System C40 | Maquet Critical Care AB | 2017-03-29 |
| K151570 | Carestation 620/650/650C | Datex-Ohmeda, Inc. | 2016-01-21 |
| K151954 | A7 Anesthesia System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2015-10-27 |
| K143530 | Aespire View | Datex-Ohmeda, Inc. | 2015-04-24 |
| K142552 | A7 Anesthesia System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2015-01-23 |
| K140264 | MADM | Thornhill Research, Inc. | 2015-01-05 |
| K132903 | DRE VENTURA | Dre Medical, Inc. | 2014-07-01 |
| K133886 | PERSEUS A500 | Draeger Medical GmbH | 2014-06-20 |
| K131790 | A9800 ANESTHESIA WORKSTATION | Oricare, Inc. | 2014-05-09 |
| K133958 | FLOW-I ANESTHESIA SYSTEM C20, C30 & C40 | Maquet Critical Care AB | 2014-03-20 |
| K132530 | GE DATEX-OHMEDA AISYS CS2 (AISYS CS^2) | Datex-Ohmeda, Inc. | 2013-12-20 |
| K131945 | GE DATEX-OHMEDA AVANCE CS2 | Datex-Ohmeda | 2013-08-08 |
| K122063 | INTELLISAVE AX700 ANESTHESIA SYSTEM | Philips Anesthesia Care | 2013-08-02 |
| K123211 | A5 ANESTHESIA DELIVERY SYSTEM | Datascope Corp., Patient Monitoring Division | 2013-02-14 |
| K123125 | GE DATEX-OHMEDA AVANCE CS2 | Datex-Ohmeda, Inc. | 2013-02-06 |
| K122445 | AESPIRE 7900, AESPIRE VIEW | Datex-Ohmeda | 2012-10-12 |
| K113633 | MCKESSON ANESTHESIA CARE | Mckesson Technologies, Inc. | 2012-04-20 |
| K103035 | SMARTPILOT VIEW MODEL MK04500 | Draeger Medical GmbH | 2012-03-28 |
| K120075 | AM-6000 ANESTHESIA MACHINE | Advanced Instrumentations, Inc. | 2012-01-26 |
| K112114 | MAQUET FLOW-I C20, MAQUET FLOW-I C30, MAQUET FLOW-I C40 | Maquet Critical Care AB | 2012-01-13 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00814905021455 | Codonics Safe Label System®(SLS) 700i Point of Care Station - 170C | CODONICS INC. | 2026-04-20 |
| 00814905021431 | Codonics Safe Label System®(SLS) 630i Point of Care Station - 170C | CODONICS INC. | 2026-04-20 |
| 00814905021400 | Codonics Safe Label System®(SLS) 610i Point of Care Station - 170C | CODONICS INC. | 2026-04-20 |
| 00814905021417 | Codonics Safe Label System®(SLS) 620i Point of Care Station - 170C | CODONICS INC. | 2026-04-20 |
| 00816711020097 | ANALGESIA GAS MIXER, DIGITAL MDM DELIVERY SYSTEM | PARKER-HANNIFIN CORPORATION | 2025-09-24 |
| 00810085200130 | Ultra PC% Oral Surgery Package H | ACCUTRON, INC. | 2025-05-14 |
| B510AM60001 | ADVANCED GAS-MACHINE ANESTHESIA | ADVANCED INSTRUMENTATIONS, INC. | 2025-02-07 |
| 05051977000857 | Penlon | PENLON LTD | 2024-12-06 |
| 06936415980702 | A3 Anesthesia Delivery System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2024-11-20 |
| 00852087007898 | Infinium Medical Inc. | INFINIUM MEDICAL, INC. | 2024-05-06 |
| 00852087007881 | Infinium Medical Inc. | INFINIUM MEDICAL, INC. | 2024-05-06 |
| 00816711024439 | DIGITAL MDM ASSY-120V(STAND MT | PARKER-HANNIFIN CORPORATION | 2024-04-05 |
| 00813830026979 | FRU, Gauge Newport O2 | ACCUTRON, INC. | 2023-10-05 |
| 10807141000091 | MADM | Thornhill Research Inc | 2020-10-01 |
| 17325710009694 | Gas sampling line (M/M connectors) 4.5m | Maquet Critical Care AB | 2020-05-28 |
| B510AM60000 | ADVANCED GAS-MACHINE ANESTHESIA | ADVANCED INSTRUMENTATIONS, INC. | 2020-05-27 |
| 17325710009687 | Gas sampling line (M/M connectors) 3.5m | Maquet Critical Care AB | 2020-05-27 |
| 17325710009670 | Gas sampling line (M/M connectors) 2.5m | Maquet Critical Care AB | 2020-05-27 |
| 07325710009765 | Flow-c Anesthesia System | Maquet Critical Care AB | 2020-05-27 |
| 06936415919085 | 2-Slot AG/O2 Module | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2020-05-12 |
| 06936415919115 | 2-Slot AG/O2/BIS Module | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2020-05-12 |
| 10841522102967 | Blease | SPACELABS HEALTHCARE (WASHINGTON), INC | 2018-07-17 |
| 10841522100420 | Spacelabs Healthcare | SPACELABS HEALTHCARE (WASHINGTON), INC | 2016-12-29 |
| 10841522100437 | Spacelabs Healthcare | SPACELABS HEALTHCARE (WASHINGTON), INC | 2016-12-29 |
| 10841522120299 | Spacelabs Healthcare | SPACELABS HEALTHCARE (WASHINGTON), INC | 2016-12-29 |
| 10841522100444 | Spacelabs Healthcare | SPACELABS HEALTHCARE (WASHINGTON), INC | 2016-12-29 |
| 07325710002513 | Gas sampling line 2.0m (M/M) | Maquet Critical Care AB | 2015-10-30 |
| 17325710004095 | Patient cassette complete | Maquet Critical Care AB | 2015-10-23 |
| 10841522100048 | BleaseGenius | SPACELABS HEALTHCARE (WASHINGTON), INC | 2015-10-19 |
| 10841522100031 | BleaseFocus | SPACELABS HEALTHCARE (WASHINGTON), INC | 2015-10-19 |