Device Classification Name |
system, measurement, blood-pressure, non-invasive
|
510(k) Number |
K021447 |
Device Name |
TELE-CLINIQ DATA TRANSMISSION SYSTEM BLOOD PRESSURE MEASUREMENT SYSTEM |
Applicant |
AEROTEL MEDICAL SYSTEMS (1998) LTD. |
377ROUTE 17 S |
HASBROUCK HEIGHT,
NJ
07604
|
|
Applicant Contact |
GEORGE MYERS |
Correspondent |
AEROTEL MEDICAL SYSTEMS (1998) LTD. |
377ROUTE 17 S |
HASBROUCK HEIGHT,
NJ
07604
|
|
Correspondent Contact |
GEORGE MYERS |
Regulation Number | 870.1130
|
Classification Product Code |
|
Date Received | 05/06/2002 |
Decision Date | 05/22/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|