510(k) Report

FDA applicant

Ohmeda Monitoring Systems

Louisville, CO1 decision1993–19930 recalls

FDA records 1 decision for Ohmeda Monitoring Systems (Louisville, CO) in 1993: 1 510(k) clearance. All are in product code DQO (Catheter, Intravascular, Diagnostic). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Ohmeda Monitoring Systems’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Ohmeda Monitoring Systems since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Ohmeda Monitoring Systems by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Ohmeda Monitoring Systems’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Ohmeda”

FDA records each applicant name separately; these may or may not be the same firm.