R & D BATTERIES,INC. PART NUMBERS 5164, 5272, 5260— 510(k) K933687

Substantially Equivalent

R & D Batteries, Inc.

FDA 510(k) clearance K933687 for R & D BATTERIES,INC. PART NUMBERS 5164, 5272, 5260, Substantially Equivalent on 1994-02-09. Applicant: R & D Batteries, Inc..

Clearance details

Applicant: R & D Batteries, Inc.
Product code: Code FKX
Advisory panel: Gastroenterology, Urology
Date received: 1993-07-29
Decision date: 1994-02-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Burnsville, MN, US

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Adverse events under product code FKX

product code FKX

Death: 501
Injury: 6,720
Malfunction: 18,508
Other: 1
Total: 25,730

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.