PAM 3000— 510(k) K082626

Substantially Equivalent

Wireless 2000 RF & Uwb Technologies , Ltd.

FDA 510(k) clearance K082626 for PAM 3000, Substantially Equivalent on 2009-01-16. Applicant: Wireless 2000 RF & Uwb Technologies , Ltd..

Clearance details

Applicant: Wireless 2000 RF & Uwb Technologies , Ltd.
Product code: Code DRT
Advisory panel: Cardiovascular
Date received: 2008-09-09
Decision date: 2009-01-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Burnaby, Bc, CA

Download summary PDF View on FDA.gov ↗

Adverse events under product code DRT

product code DRT

Death: 4
Total: 4

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.