Neuwater TM (HydrocynTM aqua)— 510(k) K142775

Substantially Equivalent

Vigilenz Medical Devices

FDA 510(k) clearance K142775 for Neuwater TM (HydrocynTM aqua), Substantially Equivalent on 2015-02-13. Applicant: Vigilenz Medical Devices.

Clearance details

Applicant: Vigilenz Medical Devices
Product code: Code FRO
Advisory panel: Unknown
Date received: 2014-09-26
Decision date: 2015-02-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bukit Minyak, MY

Download summary PDF View on FDA.gov ↗

Adverse events under product code FRO

product code FRO

Death: 30
Injury: 653
Malfunction: 479
Other: 11
Total: 1,173

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.