IREX REAL TIME PHASED ARRAY SYSTEM— 510(k) K791317

Substantially Equivalent

Irex Corp.

FDA 510(k) clearance K791317 for IREX REAL TIME PHASED ARRAY SYSTEM, Substantially Equivalent on 1979-09-17. Applicant: Irex Corp..

Clearance details

Applicant: Irex Corp.
Product code: Code CDP
Advisory panel: Clinical Chemistry
Date received: 1979-07-12
Decision date: 1979-09-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code CDP

product code CDP

Malfunction: 647
Total: 647

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.