Device Classification Name |
Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia
|
510(k) Number |
K980287 |
Device Name |
SIEMENS SC9000/SC9015 TCP02/C02 MODULE |
Applicant |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
16 ELECTRONICS AVE. |
DANVERS,
MA
01923
|
|
Applicant Contact |
JACQUELINE E EMERY |
Correspondent |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
16 ELECTRONICS AVE. |
DANVERS,
MA
01923
|
|
Correspondent Contact |
JACQUELINE E EMERY |
Regulation Number | 868.2500
|
Classification Product Code |
|
Date Received | 01/26/1998 |
Decision Date | 08/12/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|