Cleared Special

SPIDERVIEW

K032466 · Ela Medical, Inc. · Cardiovascular
Aug 2003
Decision
11d
Days
Class 2
Risk

About This 510(k) Submission

K032466 is an FDA 510(k) clearance for the SPIDERVIEW, a Electrocardiograph, Ambulatory (without Analysis) (Class II — Special Controls, product code MWJ), submitted by Ela Medical, Inc. (Plymouth, US). The FDA issued a Cleared decision on August 22, 2003, 11 days after receiving the submission on August 11, 2003. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2800.

Submission Details

510(k) Number K032466 FDA.gov
FDA Decision Cleared SESE
Date Received August 11, 2003
Decision Date August 22, 2003
Days to Decision 11 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code MWJ — Electrocardiograph, Ambulatory (without Analysis)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2800