ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER LP9— 510(k) K982896

Name: FDA 510(k) clearance K982896
Creator: U.S. Food and Drug Administration
Published: 1998-10-21

Substantially Equivalent - Subject to Tracking Reg.

Alexander Mfg. Co.

FDA 510(k) clearance K982896 for ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER LP9, Substantially Equivalent - Subject to Tracking Reg. on 1998-10-21. Applicant: Alexander Mfg. Co.. Device class: 2.

Clearance details

Applicant: Alexander Mfg. Co.
Product code: Code LDD
Device class: Class 2
Regulation: 21 CFR 870.5300
Advisory panel: Cardiovascular
Date received: 1998-08-17
Decision date: 1998-10-21
Decision: Substantially Equivalent - Subject to Tracking Reg.
Clearance type: Traditional
Location: Mason City, IA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code LDD

product code LDD

Death: 38
Malfunction: 522
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.