Cleared Traditional

PATIENT SELECTOR FUNCTION BLOCK

K832212 · Honeywell, Inc. · Cardiovascular
Oct 1983
Decision
100d
Days
Class 2
Risk

About This 510(k) Submission

K832212 is an FDA 510(k) clearance for the PATIENT SELECTOR FUNCTION BLOCK, a Electrocardiograph (Class II — Special Controls, product code DPS), submitted by Honeywell, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 14, 1983, 100 days after receiving the submission on July 6, 1983. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2340.

Submission Details

510(k) Number K832212 FDA.gov
FDA Decision Cleared SESE
Date Received July 06, 1983
Decision Date October 14, 1983
Days to Decision 100 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary —

Device Classification

Product Code DPS — Electrocardiograph
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2340