Cleared Traditional

PHYSIOLOGICAL DATA PROCESSOR

K122763 · Zephyr Technology Corporation · Cardiovascular

Jun 2013

Decision

283d

Days

Class 2

Risk

About This 510(k) Submission

K122763 is an FDA 510(k) clearance for the PHYSIOLOGICAL DATA PROCESSOR, a Transmitters And Receivers, Physiological Signal, Radiofrequency (Class II — Special Controls, product code DRG), submitted by Zephyr Technology Corporation (Stamford, US). The FDA issued a Cleared decision on June 20, 2013, 283 days after receiving the submission on September 10, 2012. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2910.

Submission Details

510(k) Number	K122763 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 10, 2012
Decision Date	June 20, 2013
Days to Decision	283 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