510(k) K133958 ยท BSZ Gas-Machine, Anesthesia
FLOW-I ANESTHESIA SYSTEM C20, C30 & C40
| Applicant | Maquet Critical Care AB, Wayne NJ, US |
| Decision | Substantially Equivalent, Mar 20, 2014 |
| Received | Dec 24, 2013 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K133958
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 6, 2024 | Getinge Usa Sales Inc Flow-i C20 Anesthesia System, model 6677200 Open, Classified |
BSZ | None listed |
| Feb 6, 2024 | Getinge Usa Sales Inc Flow-i C30 Anesthesia System, model 6677300 Open, Classified |
BSZ | None listed |
| Feb 6, 2024 | Getinge Usa Sales Inc Flow-i C40 Anesthesia System, model 6677400 Open, Classified |
BSZ | None listed |
| Feb 6, 2024 | Getinge Usa Sales Inc Flow-c Anesthesia System, model 6887700 Open, Classified |
BSZ | None listed |
| Feb 6, 2024 | Getinge Usa Sales Inc Flow-e Anesthesia System, model 6887900 Open, Classified |
BSZ | None listed |
| Feb 22, 2016 | Maquet Cardiovascular Us Sales, Llc Flow-i Anesthesia System
Product Usage:
The indication for the Flow-i Anesthesia System is administering inhalation anesthesia while controlling the entire ventilation of patients with no ability to Terminated |
BSZ | None listed |
| Jul 15, 2015 | Maquet Cardiovascular Us Sales, Llc The FLOW-i Anesthesia System Axillary O2 and Suction Module, Device Part number: 66 79 847
FLOW-i Anesthesia System: Is indicated for administering inhalation anesthesia while controlling the entire Terminated |
BSZ | None listed |
| Jun 8, 2015 | Maquet Cardiovascular Us Sales, Llc FLOW-i Anesthesia System
The FLOW-i Anesthesia System is intended for use administering inhalation anesthesia on neonatal to adult patient populations. Terminated |
BSZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.