Device Classification Name |
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
|
510(k) Number |
K883821 |
Device Name |
FEF(TM) END-TIDAL CO2 DETECTOR |
Applicant |
FENEM, INC. |
84 WILLIAM ST. |
16TH FLOOR |
NEW YORK,
NY
10038
|
|
Applicant Contact |
A GLENNON |
Correspondent |
FENEM, INC. |
84 WILLIAM ST. |
16TH FLOOR |
NEW YORK,
NY
10038
|
|
Correspondent Contact |
A GLENNON |
Regulation Number | 868.1400
|
Classification Product Code |
|
Date Received | 09/08/1988 |
Decision Date | 09/26/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|