TYPE 9225 NIBP— 510(k) K890005

Substantially Equivalent

S & W Medico Teknik

FDA 510(k) clearance K890005 for TYPE 9225 NIBP, Substantially Equivalent on 1989-05-11. Applicant: S & W Medico Teknik.

Clearance details

Applicant: S & W Medico Teknik
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 1989-01-03
Decision date: 1989-05-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Denmark, DK

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.