NBP 488, TPR 488— 510(k) K861856

Substantially Equivalent

Siemens Medical Solutions USA, Inc.

FDA 510(k) clearance K861856 for NBP 488, TPR 488, Substantially Equivalent on 1986-12-22. Applicant: Siemens Medical Solutions USA, Inc..

Clearance details

Applicant: Siemens Medical Solutions USA, Inc.
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 1986-05-14
Decision date: 1986-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Iselin, 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.