Device Classification Name |
transmitters and receivers, electrocardiograph, telephone
|
510(k) Number |
K020534 |
Device Name |
MEDSTAR SYSTEM, MODELS 533-300 |
Applicant |
CYBERNET MEDICAL |
727 AIRPORT BLVD. |
ANN ARBOR,
MI
48108
|
|
Applicant Contact |
DAVID A.C. GREEN |
Correspondent |
CYBERNET MEDICAL |
727 AIRPORT BLVD. |
ANN ARBOR,
MI
48108
|
|
Correspondent Contact |
DAVID A.C. GREEN |
Regulation Number | 870.2920
|
Classification Product Code |
|
Date Received | 02/19/2002 |
Decision Date | 02/11/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|