CALM CURVE, VERSION 01.00— 510(k) K052715

Substantially Equivalent

Lms Medical Systems (Canada), Ltd.

FDA 510(k) clearance K052715 for CALM CURVE, VERSION 01.00, Substantially Equivalent on 2005-12-22. Applicant: Lms Medical Systems (Canada), Ltd..

Clearance details

Applicant: Lms Medical Systems (Canada), Ltd.
Product code: Code HGM
Advisory panel: Obstetrics/Gynecology
Date received: 2005-09-29
Decision date: 2005-12-22
Decision: Substantially Equivalent
Clearance type: Special
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.