SENSE-4BABY SYSTEM— 510(k) K132918

Substantially Equivalent

Sense4baby , Inc.

FDA 510(k) clearance K132918 for SENSE-4BABY SYSTEM, Substantially Equivalent on 2013-11-22. Applicant: Sense4baby , Inc..

Clearance details

Applicant: Sense4baby , Inc.
Product code: Code HGM
Advisory panel: Obstetrics/Gynecology
Date received: 2013-09-17
Decision date: 2013-11-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: La Jolla, CA, 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.