ALEXANDER MFG. RECHARGEABLE BATTERY (MODEL M3)— 510(k) K970787

Substantially Equivalent

Alexander Mfg. Co.

FDA 510(k) clearance K970787 for ALEXANDER MFG. RECHARGEABLE BATTERY (MODEL M3), Substantially Equivalent on 1997-05-14. Applicant: Alexander Mfg. Co..

Clearance details

Applicant: Alexander Mfg. Co.
Product code: Code DPS
Advisory panel: Cardiovascular
Date received: 1997-03-04
Decision date: 1997-05-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mason City, IA, US

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Adverse events under product code DPS

product code DPS

Death: 7
Total: 7

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.