ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL9366— 510(k) K972786

Substantially Equivalent

Alexander Mfg. Co.

FDA 510(k) clearance K972786 for ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL9366, Substantially Equivalent on 1997-10-17. Applicant: Alexander Mfg. Co..

Clearance details

Applicant: Alexander Mfg. Co.
Product code: Code DQA
Advisory panel: Cardiovascular
Date received: 1997-07-25
Decision date: 1997-10-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mason City, IA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DQA

product code DQA

Death: 66
Malfunction: 2,867
Other: 1
Total: 2,934

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.