Device Classification Name |
Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia
|
510(k) Number |
K860951 |
Device Name |
KONTRON CUTANEOUS PO2 MONITOR 820 |
Applicant |
KONTRON INSTRUMENTS, INC. |
9 PLYMOUTH ST. |
EVERETT,
MA
02149
|
|
Applicant Contact |
GEORGE CHO |
Correspondent |
KONTRON INSTRUMENTS, INC. |
9 PLYMOUTH ST. |
EVERETT,
MA
02149
|
|
Correspondent Contact |
GEORGE CHO |
Regulation Number | 868.2500
|
Classification Product Code |
|
Date Received | 03/12/1986 |
Decision Date | 04/09/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|