MER MULTIPLANE RECTAL PROBE (MRP)— 510(k) K901033

Substantially Equivalent

Medical Equipment Resources

FDA 510(k) clearance K901033 for MER MULTIPLANE RECTAL PROBE (MRP), Substantially Equivalent on 1990-08-22. Applicant: Medical Equipment Resources.

Clearance details

Applicant: Medical Equipment Resources
Product code: Code IYO
Advisory panel: Radiology
Date received: 1990-03-06
Decision date: 1990-08-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Leandro, 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.