Cleared Traditional

K894922 - WR3500 AND WR3600 SERIES RECORDERS
(FDA 510(k) Clearance)

K894922 · Western Graphtec · Cardiovascular device

Jan 1990

Decision

177d

Days

Class 1

Risk

K894922 is an FDA 510(k) clearance for the WR3500 AND WR3600 SERIES RECORDERS. This device is classified as a Recorder, Paper Chart (Class I - General Controls, product code DSF).

Submitted by Western Graphtec (Irvine, US). The FDA issued a Cleared decision on January 26, 1990, 177 days after receiving the submission on August 2, 1989.

This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2810.

Submission Details

510(k) Number	K894922 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 02, 1989
Decision Date	January 26, 1990
Days to Decision	177 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	—