NCE REPLACEMENT BATTERIES— 510(k) K942629

Substantially Equivalent

National Custom Ent., Inc.

FDA 510(k) clearance K942629 for NCE REPLACEMENT BATTERIES, Substantially Equivalent on 1994-08-18. Applicant: National Custom Ent., Inc..

Clearance details

Applicant: National Custom Ent., Inc.
Product code: Code DPS
Advisory panel: Cardiovascular
Date received: 1994-06-03
Decision date: 1994-08-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Burnsville, MN, US

Download summary PDF View on FDA.gov ↗

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.