Cleared Traditional

K894736 - MT96000 PAPER CHART RECORDER
(FDA 510(k) Clearance)

K894736 · Astro-Med, Inc. · Cardiovascular device

Dec 1989

Decision

139d

Days

Class 1

Risk

K894736 is an FDA 510(k) clearance for the MT96000 PAPER CHART RECORDER. This device is classified as a Recorder, Paper Chart (Class I - General Controls, product code DSF).

Submitted by Astro-Med, Inc. (West Warwick, US). The FDA issued a Cleared decision on December 13, 1989, 139 days after receiving the submission on July 27, 1989.

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

Submission Details

510(k) Number	K894736 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	July 27, 1989
Decision Date	December 13, 1989
Days to Decision	139 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	—