Device Classification Name |
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
|
510(k) Number |
K983864 |
Device Name |
ETCO2 VITAL SIGNS MODULE |
Applicant |
MENNEN MEDICAL, INC. |
KIRYAT WEIZMANN SCIENCE PARK |
P.O. BOX 102 |
REHOVOT,
IL
76100
|
|
Applicant Contact |
KENNETH RAICHMAN |
Correspondent |
MENNEN MEDICAL, INC. |
KIRYAT WEIZMANN SCIENCE PARK |
P.O. BOX 102 |
REHOVOT,
IL
76100
|
|
Correspondent Contact |
KENNETH RAICHMAN |
Regulation Number | 868.1400
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 11/02/1998 |
Decision Date | 10/08/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|