Device Classification Name |
monitor, physiological, patient(with arrhythmia detection or alarms)
|
510(k) Number |
K001693 |
Device Name |
LIFE SCOPE P, MODEL BSM-4100 SERIES |
Applicant |
NIHON KOHDEN AMERICA, INC. |
2601 CAMPUS DR. |
IRVINE,
CA
92612 -1601
|
|
Applicant Contact |
BONNIE BISHOP |
Correspondent |
NIHON KOHDEN AMERICA, INC. |
2601 CAMPUS DR. |
IRVINE,
CA
92612 -1601
|
|
Correspondent Contact |
BONNIE BISHOP |
Regulation Number | 870.1025
|
Classification Product Code |
|
Date Received | 06/02/2000 |
Decision Date | 10/24/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|