BSZ — Gas-Machine, Anesthesia Class II
FDA product code BSZ covers "Gas-Machine, Anesthesia", a Class II medical device regulated under 21 CFR 868.5160. Submissions are reviewed by the Anesthesiology panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |
|---|---|---|---|
| K253330 | shenzhen mindray bio-medical electronics co | A5 Anesthesia System (A5); A7 Anesthesia System (A7) | June 25, 2026 |
| K252746 | drägerwerk ag co. kgaa | Atlan (A100); Atlan (A100 XL); Atlan(A350); Atlan (A350 XL) | May 21, 2026 |
| 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 |