Cleared Traditional

CARDIOCAP DR-124 RECORDER

K910620 · Datex Division Instrumentarium Corp. · Cardiovascular

May 1991

Decision

84d

Days

Class 2

Risk

About This 510(k) Submission

K910620 is an FDA 510(k) clearance for the CARDIOCAP DR-124 RECORDER, a Transmitters And Receivers, Physiological Signal, Radiofrequency (Class II — Special Controls, product code DRG), submitted by Datex Division Instrumentarium Corp. (Helsinki, Finland, FI). The FDA issued a Cleared decision on May 7, 1991, 84 days after receiving the submission on February 12, 1991. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2910.

Submission Details

510(k) Number	K910620 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 12, 1991
Decision Date	May 07, 1991
Days to Decision	84 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	—

Device Classification

Product Code	DRG — Transmitters And Receivers, Physiological Signal, Radiofrequency
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.2910