510(k) K170872 ยท BSZ Gas-Machine, Anesthesia
Aisys CS2
| Applicant | Datex-Ohmeda, Inc., Madison WI, US |
| Decision | Substantially Equivalent, Aug 15, 2017 |
| Received | Mar 23, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K170872
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 9, 2018 | GE Healthcare, LLC Aisys Anesthesia System. Sold under the following product names: AISYS, AISYS 10.X TO 11.X UPGRADE KIT DUTCH, AISYS 10.X TO 11.X UPGRADE KIT ENGLISH, AISYS 10.X TO 11.X UPGRADE KIT ENGLISH FOR USA, Terminated |
BSZ | None listed |
| Nov 9, 2018 | GE Healthcare, LLC Aisys CS2 Anesthesia System. Sold under the following product names: AISYS, AISYS 10.X TO 11.X UPGRADE KIT DUTCH, AISYS 10.X TO 11.X UPGRADE KIT ENGLISH, AISYS 10.X TO 11.X UPGRADE KIT ENGLISH FOR U Terminated |
BSZ | None listed |
| Nov 9, 2018 | GE Healthcare, LLC Touchscreen display kit. Sold under the following product names: TOUCHSCREEN DISPLAY KIT 11.X ENGLISH FOR USA, TOUCHSCREEN DISPLAY KIT 11.X ENGLISH, TOUCHSCREEN DISPLAY KIT 11.X GERMAN,
TOUCHSCREEN Terminated |
BSZ | None listed |
| Oct 4, 2017 | GE Healthcare, LLC DATEX-OHMEDA AISYS CS2 ALADIN2 CASSETTE
Cassettes are intended to be used to deliver anesthetic agent. Terminated |
BSZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.