Device Classification Name |
monitor, physiological, patient(with arrhythmia detection or alarms)
|
510(k) Number |
K113045 |
Device Name |
BIOHARNESS |
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 | 870.1025
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 10/13/2011 |
Decision Date | 08/14/2012 |
Decision |
substantially equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
summary |
summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|