Cleared Traditional

K851496 - ECG MONITOR MODEL RM102
(FDA 510(k) Clearance)

K851496 · Honeywell, Inc. · Cardiovascular

Jul 1985

Decision

100d

Days

Class 2

Risk

K851496 is an FDA 510(k) clearance for the ECG MONITOR MODEL RM102. This device is classified as a Display, Cathode-ray Tube, Medical (Class II — Special Controls, product code DXJ).

Submitted by Honeywell, Inc. (Pleasantville, US). The FDA issued a Cleared decision on July 24, 1985, 100 days after receiving the submission on April 15, 1985.

This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2450.

Submission Details

510(k) Number	K851496 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 15, 1985
Decision Date	July 24, 1985
Days to Decision	100 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	—