BOMED-EEA— 510(k) K853705

Substantially Equivalent

Bomed Medical Mfr., Ltd.

FDA 510(k) clearance K853705 for BOMED-EEA, Substantially Equivalent on 1986-01-13. Applicant: Bomed Medical Mfr., Ltd..

Clearance details

Applicant: Bomed Medical Mfr., Ltd.
Product code: Code DRX
Advisory panel: Cardiovascular
Date received: 1985-09-04
Decision date: 1986-01-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DRX

product code DRX

Death: 6
Injury: 476
Other: 2
Total: 484

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.