510(k) Report

FDA applicant

New England Medical Monitoring Co.

Boston, MA1 decision1995–19950 recalls

FDA records 1 decision for New England Medical Monitoring Co. (Boston, MA) in 1995: 1 510(k) clearance. All are in product code OMB (Automatic Event Detection Software For…). 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, neurology panel, where it files most

How often FDA has decided New England Medical Monitoring Co.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for New England Medical Monitoring Co. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • OMBAutomatic Event Detection Software For Full-Montage Electroencephalograph1decision

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K944833Digitrace Sleep Computer, Sleeppac, Home Sleep SystemNew England Medical Monitoring Co. · 19951cites it

What has FDA decided for it lately?

  • K944833Digitrace Sleep Computer, Sleeppac, Home Sleep SystemNew England Medical Monitoring Co. · 1995

The one decision as New England Medical Monitoring Co. →