COUPLANT WARMING DEVICE— 510(k) K893225

Substantially Equivalent

Echo Ultrasound

FDA 510(k) clearance K893225 for COUPLANT WARMING DEVICE, Substantially Equivalent on 1989-10-12. Applicant: Echo Ultrasound.

Clearance details

Applicant: Echo Ultrasound
Product code: Code IYO
Advisory panel: Radiology
Date received: 1989-04-27
Decision date: 1989-10-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lewistown, PA, 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.