INTUITION, MODEL 0170— 510(k) K073632

Substantially Equivalent

Arcoma AB

FDA 510(k) clearance K073632 for INTUITION, MODEL 0170, Substantially Equivalent on 2008-01-10. Applicant: Arcoma AB.

Clearance details

Applicant: Arcoma AB
Product code: Code KPR
Advisory panel: Radiology
Date received: 2007-12-26
Decision date: 2008-01-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Vaxjo, SE

Download summary PDF View on FDA.gov ↗

Adverse events under product code KPR

product code KPR

Other: 6
Total: 6

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.