Device Classification Name |
Transmitters And Receivers, Physiological Signal, Radiofrequency
|
510(k) Number |
K030795 |
Device Name |
LIFESYNE SYSTEMS |
Applicant |
GMP/COMPANIES, INC. |
ONE EAST BROWARD BLVD. |
SUITE 1701 |
FORT LAUDERDALE,
FL
33301
|
|
Applicant Contact |
RALPH JUGO |
Correspondent |
GMP/COMPANIES, INC. |
ONE EAST BROWARD BLVD. |
SUITE 1701 |
FORT LAUDERDALE,
FL
33301
|
|
Correspondent Contact |
RALPH JUGO |
Regulation Number | 870.2910
|
Classification Product Code |
|
Date Received | 03/12/2003 |
Decision Date | 08/05/2003 |
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
|
|
|