AQUASENS FLUID MONITORING SYSTEM— 510(k) K031213

Substantially Equivalent

Davol, Inc.

FDA 510(k) clearance K031213 for AQUASENS FLUID MONITORING SYSTEM, Substantially Equivalent on 2003-04-30. Applicant: Davol, Inc..

Clearance details

Applicant: Davol, Inc.
Product code: Code HIG
Advisory panel: Obstetrics/Gynecology
Date received: 2003-04-17
Decision date: 2003-04-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cranston, RI, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HIG

product code HIG

Death: 8
Other: 2
Total: 10

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.