Device Classification Name |
Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
|
510(k) Number |
K071606 |
Device Name |
BIOSIGN CENTRAL STATION |
Applicant |
OBS MEDICAL |
12900 N. MERIDIAN ST. STE. 120 |
CARMEL,
IN
46032
|
|
Applicant Contact |
WAYNE NETHERCUTT |
Correspondent |
OBS MEDICAL |
12900 N. MERIDIAN ST. STE. 120 |
CARMEL,
IN
46032
|
|
Correspondent Contact |
WAYNE NETHERCUTT |
Regulation Number | 870.2300
|
Classification Product Code |
|
Date Received | 06/12/2007 |
Decision Date | 08/31/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|