Cleared Traditional

SYNEFLASH & SYNEVIEW

K990727 · Ela Medical, Inc. · Cardiovascular
Nov 1999
Decision
266d
Days
Class 2
Risk

About This 510(k) Submission

K990727 is an FDA 510(k) clearance for the SYNEFLASH & SYNEVIEW, 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 November 26, 1999, 266 days after receiving the submission on March 5, 1999. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1425.

Submission Details

510(k) Number K990727 FDA.gov
FDA Decision Cleared SESE
Date Received March 05, 1999
Decision Date November 26, 1999
Days to Decision 266 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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