BABY FACE— 510(k) K994385

Substantially Equivalent

Sonora Medical Systems

FDA 510(k) clearance K994385 for BABY FACE, Substantially Equivalent on 2000-03-16. Applicant: Sonora Medical Systems.

Clearance details

Applicant: Sonora Medical Systems
Product code: Code IYO
Advisory panel: Radiology
Date received: 1999-12-28
Decision date: 2000-03-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Longmont, CO, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code IYO

product code IYO

Malfunction: 3,339
Total: 3,339

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.