Device Classification Name |
Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia
|
510(k) Number |
K925910 |
Device Name |
HEWLETT-PACKARD MODEL M1018A TCPO2/TOPCO2 MODULE |
Applicant |
HEWLETT-PACKARD CO. |
SCHUCKARDSTRABE 4 |
7030 BOBLINGEN |
GERMANY,
DE
|
|
Applicant Contact |
VAN DYK |
Correspondent |
HEWLETT-PACKARD CO. |
SCHUCKARDSTRABE 4 |
7030 BOBLINGEN |
GERMANY,
DE
|
|
Correspondent Contact |
VAN DYK |
Regulation Number | 868.2500
|
Classification Product Code |
|
Date Received | 11/23/1992 |
Decision Date | 07/29/1993 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|