K153026

Substantially Equivalent

Body Pro-Lok Respiratory Plate, Respiratory Plate Cushion, Body Pro-Respiratory Belt, Rail Clamp for Respiratory Belt, Pressure Gauge Replacement

Applicant: Medtec, Inc. D/B/A Civco Medical Solutions
Product code: IYE
Advisory panel: Radiology
Date received: 2015-10-16
Decision date: 2016-05-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Orange City, IA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code IYE

product code IYE

Malfunction: 455
Other: 3
Total: 458

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.