K951401

Substantially Equivalent

R&D BATTERIES PART NOS. 5015, 5016, 5037 AND 5051

Applicant: R & D Batteries, Inc.
Product code: FLL
Advisory panel: General Hospital
Date received: 1995-03-28
Decision date: 1995-08-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Burnsville, MN, US

Adverse events under product code FLL

product code FLL

Death: 3
Malfunction: 557
Total: 560

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.