DeviceClearance

K951281

Substantially Equivalent

R&D BATTERIS, INC. PART NUMBER 5024, 5027, 5033 AND 5035

Applicant
R & D Batteries, Inc.
Product code
FLL
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Burnsville, MN, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code FLL

product code FLL
Death
3
Malfunction
557
Total
560

Source: openFDA MAUDE database, through . 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.