ULTRASCAN DIGITAL B— 510(k) K842757

Substantially Equivalent

CooperVision, Inc.

FDA 510(k) clearance K842757 for ULTRASCAN DIGITAL B, Substantially Equivalent on 1985-01-09. Applicant: CooperVision, Inc..

Clearance details

Applicant: CooperVision, Inc.
Product code: Code IYO
Advisory panel: Radiology
Date received: 1984-07-16
Decision date: 1985-01-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, 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.