SURELOCK(TM) SNAPLESS MONITORING ELECTRODE— 510(k) K931903

Substantially Equivalent

Ludlow Technical Products

FDA 510(k) clearance K931903 for SURELOCK(TM) SNAPLESS MONITORING ELECTRODE, Substantially Equivalent on 1993-10-07. Applicant: Ludlow Technical Products.

Clearance details

Applicant: Ludlow Technical Products
Product code: Code DRX
Advisory panel: Cardiovascular
Date received: 1993-04-15
Decision date: 1993-10-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chicopee, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DRX

product code DRX

Death: 6
Injury: 476
Other: 2
Total: 484

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.