MC-245, MC-246, MC-247, MC-341, MC-343, MC-344— 510(k) K091676

Substantially Equivalent

Omron Healthcare, Inc.

FDA 510(k) clearance K091676 for MC-245, MC-246, MC-247, MC-341, MC-343, MC-344, Substantially Equivalent on 2009-09-01. Applicant: Omron Healthcare, Inc..

Clearance details

Applicant: Omron Healthcare, Inc.
Product code: Code FLL
Advisory panel: General Hospital
Date received: 2009-06-09
Decision date: 2009-09-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bonita Springs, FL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FLL

product code FLL

Death: 3
Malfunction: 557
Total: 560

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.