CYCLE BP MONITOR AND PULSE OXIMETER, MODEL 1060— 510(k) K060820

Substantially Equivalent

Suntech Medical, Inc.

FDA 510(k) clearance K060820 for CYCLE BP MONITOR AND PULSE OXIMETER, MODEL 1060, Substantially Equivalent on 2006-06-07. Applicant: Suntech Medical, Inc..

Clearance details

Applicant: Suntech Medical, Inc.
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 2006-03-27
Decision date: 2006-06-07
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Morrisville, NC, US

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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.