Cleared Traditional

K002817 - SYNETEC
(FDA 510(k) Clearance)

K002817 · Ela Medical, Inc. · Cardiovascular

May 2001

Decision

233d

Days

Class 2

Risk

K002817 is an FDA 510(k) clearance for the SYNETEC. This device is classified as 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 May 2, 2001, 233 days after receiving the submission on September 11, 2000.

This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1425.

Submission Details

510(k) Number	K002817 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 11, 2000
Decision Date	May 02, 2001
Days to Decision	233 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF