CALM— 510(k) K980719

Substantially Equivalent

Lms Medical Systems , Ltd.

FDA 510(k) clearance K980719 for CALM, Substantially Equivalent on 1998-07-31. Applicant: Lms Medical Systems , Ltd..

Clearance details

Applicant: Lms Medical Systems , Ltd.
Product code: Code HGM
Advisory panel: Obstetrics/Gynecology
Date received: 1998-02-24
Decision date: 1998-07-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Montreal, Qc, CA

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Adverse events under product code HGM

product code HGM

Death: 35
Malfunction: 478
Total: 513

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.