ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER LP5-FP— 510(k) K971604

Name: FDA 510(k) clearance K971604
Creator: U.S. Food and Drug Administration
Published: 1997-07-28

Substantially Equivalent

Alexander Mfg. Co.

FDA 510(k) clearance K971604 for ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER LP5-FP, Substantially Equivalent on 1997-07-28. Applicant: Alexander Mfg. Co.. Device class: 2.

Clearance details

Applicant: Alexander Mfg. Co.
Product code: Code DSH
Device class: Class 2
Regulation: 21 CFR 870.2800
Advisory panel: Cardiovascular
Date received: 1997-05-01
Decision date: 1997-07-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mason City, IA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code DSH

product code DSH

Death: 3
Injury: 652
Total: 655

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.