Cleared Traditional

HEART RATE VARIABILITY SOFTWARE OPTION

K950779 · Spacelabs, Inc. · Cardiovascular
Apr 1995
Decision
63d
Days
Class 2
Risk

About This 510(k) Submission

K950779 is an FDA 510(k) clearance for the HEART RATE VARIABILITY SOFTWARE OPTION, a Electrocardiograph (Class II — Special Controls, product code DPS), submitted by Spacelabs, Inc. (Redmond, US). The FDA issued a Cleared decision on April 25, 1995, 63 days after receiving the submission on February 21, 1995. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2340.

Submission Details

510(k) Number K950779 FDA.gov
FDA Decision Cleared SESE
Date Received February 21, 1995
Decision Date April 25, 1995
Days to Decision 63 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement

Device Classification

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