Cleared Traditional

SYNESCOPE, EASYSCOPE, SYNECOM, HOLTERREADER

K042002 · Ela Medical, Inc. · Cardiovascular
Oct 2004
Decision
86d
Days
Class 2
Risk

About This 510(k) Submission

K042002 is an FDA 510(k) clearance for the SYNESCOPE, EASYSCOPE, SYNECOM, HOLTERREADER, a Computer, Diagnostic, Programmable (Class II — Special Controls, product code DQK), submitted by Ela Medical, Inc. (Plymouth, US). The FDA issued a Cleared decision on October 20, 2004, 86 days after receiving the submission on July 26, 2004. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1425.

Submission Details

510(k) Number K042002 FDA.gov
FDA Decision Cleared SESE
Date Received July 26, 2004
Decision Date October 20, 2004
Days to Decision 86 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DQK — Computer, Diagnostic, Programmable
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1425

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