ZP9141, ZP9146Y, ZP9146W NON-RECHARGEABLE BATTERY— 510(k) K141231

Name: FDA 510(k) clearance K141231
Creator: U.S. Food and Drug Administration
Published: 2014-11-25

Substantially Equivalent

Zeller Power Products (Battery Beast, LLC)

FDA 510(k) clearance K141231 for ZP9141, ZP9146Y, ZP9146W NON-RECHARGEABLE BATTERY, Substantially Equivalent on 2014-11-25. Applicant: Zeller Power Products (Battery Beast, LLC). Device class: 3.

Clearance details

Applicant: Zeller Power Products (Battery Beast, LLC)
Product code: Code MKJ
Device class: Class 3
Regulation: 21 CFR 870.5310
Advisory panel: Cardiovascular
Date received: 2014-05-13
Decision date: 2014-11-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Las Vegas, NV, US

Download summary PDF View on FDA.gov ↗

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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.