Cleared Traditional

E-PAIN CARE

K041714 · Breg, Inc. · General Hospital
Oct 2004
Decision
100d
Days
Class 2
Risk

About This 510(k) Submission

K041714 is an FDA 510(k) clearance for the E-PAIN CARE, a Pump, Infusion (Class II — Special Controls, product code FRN), submitted by Breg, Inc. (Vista, US). The FDA issued a Cleared decision on October 1, 2004, 100 days after receiving the submission on June 23, 2004. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number K041714 FDA.gov
FDA Decision Cleared SESE
Date Received June 23, 2004
Decision Date October 01, 2004
Days to Decision 100 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement

Device Classification

Product Code FRN — Pump, Infusion
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5725

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