OSCAR 2, MODEL 222— 510(k) K003004

Substantially Equivalent

Suntech Medical Instruments, Inc.

FDA 510(k) clearance K003004 for OSCAR 2, MODEL 222, Substantially Equivalent on 2000-10-25. Applicant: Suntech Medical Instruments, Inc..

Clearance details

Applicant: Suntech Medical Instruments, Inc.
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 2000-09-25
Decision date: 2000-10-25
Decision: Substantially Equivalent
Clearance type: Special
Location: Hasbrouck Heights, NJ, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DXN

product code DXN

Death: 3
Injury: 169
Malfunction: 1,019
Other: 2
Total: 1,193

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.