Cleared Traditional

AQUASENS FLUID MONITORING SYSTEM

K031213 · Davol, Inc. · Obstetrics & Gynecology
Apr 2003
Decision
13d
Days
Class 2
Risk

About This 510(k) Submission

K031213 is an FDA 510(k) clearance for the AQUASENS FLUID MONITORING SYSTEM, a Insufflator, Hysteroscopic (Class II — Special Controls, product code HIG), submitted by Davol, Inc. (Cranston, US). The FDA issued a Cleared decision on April 30, 2003, 13 days after receiving the submission on April 17, 2003. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.1700.

Submission Details

510(k) Number K031213 FDA.gov
FDA Decision Cleared SESE
Date Received April 17, 2003
Decision Date April 30, 2003
Days to Decision 13 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF

Device Classification

Product Code HIG — Insufflator, Hysteroscopic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.1700

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