Device Classification Name |
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
|
510(k) Number |
K930957 |
Device Name |
ZEFON GAS SAMPLING LINES |
Applicant |
ZEFON MEDICAL PRODUCTS |
5350 SOUTHWEST FIRST LN. |
OCALA,
FL
34474
|
|
Applicant Contact |
ROBERT STONE |
Correspondent |
ZEFON MEDICAL PRODUCTS |
5350 SOUTHWEST FIRST LN. |
OCALA,
FL
34474
|
|
Correspondent Contact |
ROBERT STONE |
Regulation Number | 868.1400
|
Classification Product Code |
|
Date Received | 02/23/1993 |
Decision Date | 07/02/1993 |
Decision |
Substantially Equivalent - Kit
(SESK) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|