BSZ — Gas-Machine, Anesthesia Class II
FDA Device Classification
Classification Details
- Product Code
- BSZ
- Device Class
- Class II
- Regulation Number
- 868.5160
- Submission Type
- Review Panel
- AN
- Medical Specialty
- Anesthesiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K251352 | codonics.incorporated | Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-700i and related | July 11, 2025 |
| K230931 | drägerwerk ag co. kgaa | Atlan | July 23, 2023 |
| K213867 | datex-ohmeda | Carestation 750/750c | March 28, 2023 |
| K201957 | shenzhen mindray bio-medical electronics co | A8, A9 Anesthesia System | March 26, 2021 |
| K191027 | maquet critical care | Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia System | March 18, 2020 |
| K171292 | shenzhen mindray bio-medical electronics co | A7 Anesthesia System | January 12, 2018 |
| K171311 | shenzhen mindray bio-medical electronics co | A5 Anesthesia System | January 12, 2018 |
| K172045 | datex-ohmeda | Aestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7100 Compact, Aespire 100, Aesp | November 3, 2017 |
| K170872 | datex-ohmeda | Aisys CS2 | August 15, 2017 |
| K160665 | maquet critical care | FLOW-i Anesthesia System C20, FLOW-i Anesthesia System C30, FLOW-i Anesthesia Sy | March 29, 2017 |
| K151570 | datex-ohmeda | Carestation 620/650/650C | January 21, 2016 |
| K151954 | shenzhen mindray bio-medical electronics co | A7 Anesthesia System | October 27, 2015 |
| K143530 | datex-ohmeda | Aespire View | April 24, 2015 |
| K142552 | shenzhen mindray bio-medical electronics co | A7 Anesthesia System | January 23, 2015 |
| K140264 | thornhill research | MADM | January 5, 2015 |
| K132903 | dre medical | DRE VENTURA | July 1, 2014 |
| K133886 | draeger medical | PERSEUS A500 | June 20, 2014 |
| K131790 | oricare | A9800 ANESTHESIA WORKSTATION | May 9, 2014 |
| K133958 | maquet critical care | FLOW-I ANESTHESIA SYSTEM C20, C30 & C40 | March 20, 2014 |
| K132530 | datex-ohmeda | GE DATEX-OHMEDA AISYS CS2 (AISYS CS^2) | December 20, 2013 |