PRIMADO— 510(k) K083112

Substantially Equivalent

Nakanishi, Inc.

FDA 510(k) clearance K083112 for PRIMADO, Substantially Equivalent on 2009-04-29. Applicant: Nakanishi, Inc..

Clearance details

Applicant: Nakanishi, Inc.
Product code: Code HBC
Advisory panel: Neurology
Date received: 2008-10-21
Decision date: 2009-04-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HBC

product code HBC

Malfunction: 4,715
Total: 4,715

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.