510(k) K000706 ยท BSZ Gas-Machine, Anesthesia
DATEX-OHMEDA AESTIVA/5 WITH 7100 VENTILATOR
| Applicant | Datex-Ohmeda, Inc., Madison WI, US |
| Decision | Substantially Equivalent, May 11, 2000 |
| Received | Mar 2, 2000 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K000706
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 19, 2019 | GE Healthcare, LLC Aespire 7100, Model Numbers:
1. 1009-9000-000-009469
2. 1009-9000-000
3. 1009-9000-000-013913
4. 1009-9000-000-001366
5. 1009-9000-000-009857
6. 1009-9003-000
7. 1009-9000-000-008120
8. 1009-9000-00 Terminated |
BSZ | None listed |
| Jul 19, 2019 | GE Healthcare, LLC Aestiva 7100, Model Numbers:
1. 1006-9320-000
2. 1006-9321-000
3. 1006-9320-000-001101
4. 1006-9021-000
5. 1006-9012-000
6. 1006-9111-000
7. 1006-9321-000-007639
8. 1006-9321-000-000023
9. 1006-9321 Terminated |
BSZ | None listed |
| Oct 12, 2005 | Datex-Ohmeda Inc Datex-Ohmeda S/5 Aespire Anesthesia System 7100 Terminated |
BSZ | None listed |
| Jul 20, 2004 | Datex-Ohmeda Inc Datex-Ohmeda Aestiva/5 Active Gas Scavenging System, used with a Model 7100 Ventillator, on a Aestiva/5 Anesthesia Machine. Terminated |
CBN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.