FDA applicant

Itamar Medical (C.M.) 1997, Ltd.

Hasbrouck Heights, NJ3 decisions2001–20020 recalls

FDA records 3 decisions for Itamar Medical (C.M.) 1997, Ltd. (Hasbrouck Heights, NJ) from 2001 to 2002: 3 510(k) clearances. Most are in product codes MNR (Ventilatory Effort Recorder) and DQK (Computer, Diagnostic, Programmable). 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, anesthesiology panel, where it files most

How often FDA has decided Itamar Medical (C.M.) 1997, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Itamar Medical (C.M.) 1997, Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Itamar Medical (C.M.) 1997, Ltd. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Itamar Medical (C.M.) 1997, Ltd.’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 “Itamar”

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

Itamar Medical, Ltd. 17

Itamar Medical (C.M.) 1997, Ltd.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Itamar”