EOS— 510(k) K071546

Substantially Equivalent

Biospace Med

FDA 510(k) clearance K071546 for EOS, Substantially Equivalent on 2007-09-18. Applicant: Biospace Med.

Clearance details

Applicant: Biospace Med
Product code: Code KPR
Advisory panel: Radiology
Date received: 2007-06-06
Decision date: 2007-09-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

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.