510(k) K122763

PHYSIOLOGICAL DATA PROCESSOR by Zephyr Technology Corporation — Product Code DRG

K122763 is an FDA 510(k) premarket notification submitted by Zephyr Technology Corporation for the device "PHYSIOLOGICAL DATA PROCESSOR". The FDA issued a decision of Substantially Equivalent on June 20, 2013. The device falls under product code DRG (Transmitters And Receivers, Physiological Signal, Radiofrequency), a Class II device regulated under 21 CFR 870.2910. Zephyr Technology Corporation has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 20, 2013
Date Received
September 10, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transmitters And Receivers, Physiological Signal, Radiofrequency
Device Class
Class II
Regulation Number
870.2910
Review Panel
CV
Submission Type