Device Classification Name |
Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia
|
510(k) Number |
K811836 |
Device Name |
PO-200 BLOOD OXYGEN MONITOR |
Applicant |
SUMITOMO ELECTRIC INDUSTRIES, INC. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Correspondent |
SUMITOMO ELECTRIC INDUSTRIES, INC. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Regulation Number | 868.2500
|
Classification Product Code |
|
Date Received | 06/30/1981 |
Decision Date | 07/27/1981 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|