NIO-P— 510(k) K160805

Substantially Equivalent

Waismed, Ltd.

FDA 510(k) clearance K160805 for NIO-P, Substantially Equivalent on 2016-06-23. Applicant: Waismed, Ltd..

Clearance details

Applicant: Waismed, Ltd.
Product code: Code FMI
Advisory panel: General Hospital
Date received: 2016-03-23
Decision date: 2016-06-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rosh Ha'Ayin, IL

Download summary PDF View on FDA.gov ↗

Adverse events under product code FMI

product code FMI

Death: 28
Injury: 1,517
Malfunction: 23,981
Other: 18
Total: 25,544

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.