Cleared Traditional

MODIFICATION OF: PHYSIOLOGICAL SIGNAL TRANSMITTER AND RECEIVER, MODEL 3810A

K993169 · Hewlett-Packard Co. · Cardiovascular

Dec 1999

Decision

89d

Days

Class 2

Risk

About This 510(k) Submission

K993169 is an FDA 510(k) clearance for the MODIFICATION OF: PHYSIOLOGICAL SIGNAL TRANSMITTER AND RECEIVER, MODEL 3810A, a Transmitters And Receivers, Physiological Signal, Radiofrequency (Class II — Special Controls, product code DRG), submitted by Hewlett-Packard Co. (Los Altos, US). The FDA issued a Cleared decision on December 20, 1999, 89 days after receiving the submission on September 22, 1999. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2910.

Submission Details

510(k) Number	K993169 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 22, 1999
Decision Date	December 20, 1999
Days to Decision	89 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF

Device Classification

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