510(k) Report

FDA applicant

Sagatech Electronics, Inc.

Calgary, Alberta, CA1 decision2002–20021 recall

FDA records 1 decision for Sagatech Electronics, Inc. (Calgary, Alberta, CA) in 2002: 1 510(k) clearance. All are in product code MNR (Ventilatory Effort Recorder). 1 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 Sagatech Electronics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Sagatech Electronics, Inc. since 2007.

Recalls per year

1in 2008

2008: 1
2007high 1 (2008) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Sagatech Electronics, Inc. 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?

  • MNRVentilatory Effort Recorder1decision

What has FDA decided for it lately?

  • K002159Snore Sat Recorder, Model SS41Sagatech Electronics, Inc. · 20021 recall

The one decision as Sagatech Electronics, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K002159Finger Sensor for Remmers Recorder (Formerly SnoreSat Sleep recorder) To be used to…May 8, 2008Class II