TECNOL SECURE-ALL FETAL MONITOR STRAP— 510(k) K861189

Substantially Equivalent

Tecnol New Jersey Wound Care, Inc.

FDA 510(k) clearance K861189 for TECNOL SECURE-ALL FETAL MONITOR STRAP, Substantially Equivalent on 1986-04-08. Applicant: Tecnol New Jersey Wound Care, Inc..

Clearance details

Applicant: Tecnol New Jersey Wound Care, Inc.
Product code: Code HGM
Advisory panel: Obstetrics/Gynecology
Date received: 1986-03-31
Decision date: 1986-04-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fort Worth, TX, US

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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.