PRESSURE TRAK, MODEL 222-B— 510(k) K010622

Substantially Equivalent

Suntech Medical Instruments, Inc.

FDA 510(k) clearance K010622 for PRESSURE TRAK, MODEL 222-B, Substantially Equivalent on 2001-03-29. Applicant: Suntech Medical Instruments, Inc..

Clearance details

Applicant: Suntech Medical Instruments, Inc.
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 2001-03-02
Decision date: 2001-03-29
Decision: Substantially Equivalent
Clearance type: Special
Location: Raleigh, NC, 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.