ES 22— 510(k) K854243

Substantially Equivalent

Boehringer Mannheim Corp.

FDA 510(k) clearance K854243 for ES 22, Substantially Equivalent on 1985-11-19. Applicant: Boehringer Mannheim Corp..

Clearance details

Applicant: Boehringer Mannheim Corp.
Product code: Code JJE
Advisory panel: Clinical Chemistry
Date received: 1985-10-21
Decision date: 1985-11-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code JJE

product code JJE

Death: 6
Injury: 441
Malfunction: 25,011
Other: 1
Total: 25,459

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.