PACIFICA— 510(k) K073407

Substantially Equivalent

Or-Nim Medical , Ltd.

FDA 510(k) clearance K073407 for PACIFICA, Substantially Equivalent on 2008-02-28. Applicant: Or-Nim Medical , Ltd..

Clearance details

Applicant: Or-Nim Medical , Ltd.
Product code: Code MUD
Advisory panel: Cardiovascular
Date received: 2007-12-04
Decision date: 2008-02-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MUD

product code MUD

Malfunction: 467
Total: 467

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.