Device Classification Name |
oximeter
|
510(k) Number |
K901819 |
Device Name |
MODEL 78834C NEONATAL PULSE OXIMETER (SAO2) |
Applicant |
HEWLETT-PACKARD CO. |
SCHUCKARDSTRABE 4 |
7030 BOBLINGEN |
GERMANY,
DE
|
|
Applicant Contact |
GERHARD LENKE |
Correspondent |
HEWLETT-PACKARD CO. |
SCHUCKARDSTRABE 4 |
7030 BOBLINGEN |
GERMANY,
DE
|
|
Correspondent Contact |
GERHARD LENKE |
Regulation Number | 870.2700
|
Classification Product Code |
|
Date Received | 04/23/1990 |
Decision Date | 07/18/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|