OMEGA CARES SYSTEM— 510(k) K945068

Substantially Equivalent

J-F Medical Systems Intl., Inc.

FDA 510(k) clearance K945068 for OMEGA CARES SYSTEM, Substantially Equivalent on 1996-01-25. Applicant: J-F Medical Systems Intl., Inc..

Clearance details

Applicant: J-F Medical Systems Intl., Inc.
Product code: Code DQK
Advisory panel: Cardiovascular
Date received: 1994-10-14
Decision date: 1996-01-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carrollton, TX, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DQK

product code DQK

Death: 10
Injury: 225
Malfunction: 2,123
Other: 2
Total: 2,360

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.