Cleared Traditional

DRIP ALERT

K030136 · Drip Alert, Inc. · General Hospital
Apr 2003
Decision
83d
Days
Class 2
Risk

About This 510(k) Submission

K030136 is an FDA 510(k) clearance for the DRIP ALERT, a Monitor, Electric For Gravity Flow Infusion Systems (Class II — Special Controls, product code FLN), submitted by Drip Alert, Inc. (Ft. Lauderdale, US). The FDA issued a Cleared decision on April 7, 2003, 83 days after receiving the submission on January 14, 2003. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.2420.

Submission Details

510(k) Number K030136 FDA.gov
FDA Decision Cleared SESE
Date Received January 14, 2003
Decision Date April 07, 2003
Days to Decision 83 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FLN — Monitor, Electric For Gravity Flow Infusion Systems
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.2420