Cleared Traditional

TELEMETRY, BIOMEDICAL

K790109 · Lkc Technologies, Inc. · Cardiovascular

Mar 1979

Decision

58d

Days

Class 2

Risk

About This 510(k) Submission

K790109 is an FDA 510(k) clearance for the TELEMETRY, BIOMEDICAL, a Transmitters And Receivers, Physiological Signal, Radiofrequency (Class II — Special Controls, product code DRG), submitted by Lkc Technologies, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 16, 1979, 58 days after receiving the submission on January 17, 1979. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2910.

Submission Details

510(k) Number	K790109 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 17, 1979
Decision Date	March 16, 1979
Days to Decision	58 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