Device Classification Name |
Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia
|
510(k) Number |
K802846 |
Device Name |
TCM202 TCPO2 & TCM204 TCPO2/PO2 REC. SY. |
Applicant |
THE LONDON CO. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
THE LONDON CO. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 868.2500
|
Classification Product Code |
|
Date Received | 11/12/1980 |
Decision Date | 12/17/1980 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|