Device Classification Name |
arterial blood sampling kit
|
510(k) Number |
K811860 |
Device Name |
EASY-FLO ARTERIAL BLOOD GAS KIT |
Applicant |
DHD MEDICAL PRODUCTS DIV. DIEMOLDING CORP. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
DHD MEDICAL PRODUCTS DIV. DIEMOLDING CORP. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 868.1100
|
Classification Product Code |
|
Date Received | 07/01/1981 |
Decision Date | 07/16/1981 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|