Device Classification Name |
Transmitters And Receivers, Physiological Signal, Radiofrequency
|
510(k) Number |
K122763 |
Device Name |
PHYSIOLOGICAL DATA PROCESSOR |
Applicant |
ZEPHYR TECHNOLOGY CORPORATION |
1151 HOPE STREET |
STAMFORD,
CT
06907
|
|
Applicant Contact |
RICHARD KEEN |
Correspondent |
ZEPHYR TECHNOLOGY CORPORATION |
1151 HOPE STREET |
STAMFORD,
CT
06907
|
|
Correspondent Contact |
RICHARD KEEN |
Regulation Number | 870.2910
|
Classification Product Code |
|
Date Received | 09/10/2012 |
Decision Date | 06/20/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|