Device Classification Name |
Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
|
510(k) Number |
K082626 |
Device Name |
PAM 3000 |
Applicant |
WIRELESS 2000 RF & UWB TECHNOLOGIES LTD. |
2421 ALPHA AVE |
BURNABY, BC,
CA
V5C5L2
|
|
Applicant Contact |
EFRAIM GAVRILOVICH |
Correspondent |
WIRELESS 2000 RF & UWB TECHNOLOGIES LTD. |
2421 ALPHA AVE |
BURNABY, BC,
CA
V5C5L2
|
|
Correspondent Contact |
EFRAIM GAVRILOVICH |
Regulation Number | 870.2300
|
Classification Product Code |
|
Date Received | 09/09/2008 |
Decision Date | 01/16/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|