ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS5169— 510(k) K971099

Substantially Equivalent

Alexander Mfg. Co.

FDA 510(k) clearance K971099 for ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS5169, Substantially Equivalent on 1997-06-05. Applicant: Alexander Mfg. Co..

Clearance details

Applicant: Alexander Mfg. Co.
Product code: Code HGM
Advisory panel: Obstetrics/Gynecology
Date received: 1997-03-26
Decision date: 1997-06-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mason City, IA, US

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Adverse events under product code HGM

product code HGM

Death: 35
Malfunction: 478
Total: 513

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.