SMARTLANK WIRELESS, MODEL 001970— 510(k) K033642

Substantially Equivalent

Mrl, A Welch Allyn Company

FDA 510(k) clearance K033642 for SMARTLANK WIRELESS, MODEL 001970, Substantially Equivalent on 2004-05-25. Applicant: Mrl, A Welch Allyn Company.

Clearance details

Applicant: Mrl, A Welch Allyn Company
Product code: Code MKJ
Advisory panel: Cardiovascular
Date received: 2003-11-20
Decision date: 2004-05-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Skaneateles Falls, NY, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MKJ

product code MKJ

Death: 961
Injury: 1,070
Malfunction: 90,719
Other: 8
Total: 92,758

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.