Device Classification Name |
humidifier, respiratory gas, (direct patient interface)
|
510(k) Number |
K932570 |
Device Name |
MARK I HUMIDIFIER |
Applicant |
C.F. ELECTRONICS, INC. |
5 BRAYTON COURT |
COMMACK,
NY
11725
|
|
Applicant Contact |
ROBERT FREEDMAN |
Correspondent |
C.F. ELECTRONICS, INC. |
5 BRAYTON COURT |
COMMACK,
NY
11725
|
|
Correspondent Contact |
ROBERT FREEDMAN |
Regulation Number | 868.5450
|
Classification Product Code |
|
Date Received | 05/27/1993 |
Decision Date | 08/25/1993 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|