The following data is part of a premarket notification filed by Zephyr Technology Corporation with the FDA for Physiological Data Processor.
Device ID | K122763 |
510k Number | K122763 |
Device Name: | PHYSIOLOGICAL DATA PROCESSOR |
Classification | Transmitters And Receivers, Physiological Signal, Radiofrequency |
Applicant | ZEPHYR TECHNOLOGY CORPORATION 1151 HOPE STREET Stamford, CT 06907 |
Contact | Richard Keen |
Correspondent | Richard Keen ZEPHYR TECHNOLOGY CORPORATION 1151 HOPE STREET Stamford, CT 06907 |
Product Code | DRG |
CFR Regulation Number | 870.2910 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-09-10 |
Decision Date | 2013-06-20 |
Summary: | summary |