Device Classification Name |
System, Measurement, Blood-Pressure, Non-Invasive
|
510(k) Number |
K945947 |
Device Name |
NELLCOR SYMPHONY(TM) N-3100 BLOOD PRESSURE MONITOR AND CONNECTED TO THE NELLCOR SYMPHONY(TM) N-3000 PULSE OXIMETER |
Applicant |
NELLCOR, INC. |
11150 THOMPSON AVE. |
LENEXA,
KS
66219
|
|
Applicant Contact |
DAVID GREEN |
Correspondent |
NELLCOR, INC. |
11150 THOMPSON AVE. |
LENEXA,
KS
66219
|
|
Correspondent Contact |
DAVID GREEN |
Regulation Number | 870.1130
|
Classification Product Code |
|
Date Received | 12/06/1994 |
Decision Date | 03/08/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|