510(k) K042419 ยท BSZ Gas-Machine, Anesthesia
FABIUS GS/FABIUS TIRO ANESTHESIA SYSTEM
| Applicant | Draeger Medical, Inc., Telford PA, US |
| Decision | Substantially Equivalent, Oct 8, 2004 |
| Received | Sep 7, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K042419
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 24, 2018 | Draeger Medical, Inc. Fabius GS Premium Anesthesia Machine; Cat. no. 8607000
Product Usage:
Inhalation anesthesia machines for use in operating, induction and recovery rooms. They may be used with O2, N2O, and AIR supplie Terminated |
BSZ | None listed |
| May 24, 2018 | Draeger Medical, Inc. Fabius GS Tiro Anesthesia Machine; Cat. no. 8606000
Product Usage:
Inhalation anesthesia machines for use in operating, induction and recovery rooms. They may be used with O2, N2O, and AIR supplied b Terminated |
BSZ | None listed |
| May 8, 2018 | Draeger Medical, Inc. Fabius GS Premium, anesthesia machine, catalog no. 8607000
Product Usage:
The products are inhalation anesthesia machines for use in operating, induction and recovery rooms. They may be used with O2, Terminated |
BSZ | None listed |
| May 8, 2018 | Draeger Medical, Inc. Fabius Tiro, anesthesia machine, catalog no. 8606000
Product Usage:
The products are inhalation anesthesia machines for use in operating, induction and recovery rooms. They may be used with O2, N2O, Terminated |
BSZ | None listed |
| May 8, 2018 | Draeger Medical, Inc. Fabius Tiro M, anesthesia machine, catalog no. 8608400
Product Usage:
The products are inhalation anesthesia machines for use in operating, induction and recovery rooms. They may be used with O2, N2O Terminated |
BSZ | None listed |
| Oct 10, 2013 | Draeger Medical, Inc. Draeger Fabius GS Premium, Fabius OS, Fabius Tiro, Fabius Tiro D-M
Product Usage:
used to administer anesthesia and ventilation to patients during surgical procedures. Terminated |
BSZ | None listed |
| Sep 23, 2010 | Draeger Medical Systems, Inc. Fabius GS Anesthesia Machine, OR/Anesthesia, Draeger Medical, Inc., 3135 Quarry Road, Telford, PA 18969
inhalation anesthesia machine for use in operating, induction and recovery rooms Terminated |
BSZ | None listed |
| Sep 23, 2010 | Draeger Medical Systems, Inc. Fabius Tiro Anesthesia Machine, OR/Anesthesia, Draeger Medical, Inc., 3135 Quarry Road, Telford, PA 18969
Compact anesthesia system that offers the full spectrum of anesthesia ventilation to military Terminated |
BSZ | None listed |
| Sep 23, 2008 | Draeger Medical, Inc. Fabius Trio Gas machine, anesthesia or analgesia. Catalog number 8606000. The product is used in operating rooms and ER, for patient intubation. Terminated |
BSZ | None listed |
| Jul 16, 2008 | Draeger Medical, Inc. Fabius GS Anesthesia Machine; Gas machine for anesthesia or analgesia; Catalog Number: 8604700; Drager Medical Inc, Telford, PA 18969. Terminated |
BSZ | None listed |
| Oct 19, 2006 | Draeger Medical, Inc. Fabius GS Anesthesia Machine. Catalog number 8604699 Terminated |
BSZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.