Device Classification Name |
Ventilator, Continuous, Facility Use
|
510(k) Number |
K860798 |
Device Name |
ARF-1500 CONTINUOUS VENTILATOR |
Applicant |
MEDIMEX, INC. |
300 HEMPSTEAD TPKE |
WEST HEMPSTEAD,
NY
11552
|
|
Applicant Contact |
WALTER LEDER |
Correspondent |
MEDIMEX, INC. |
300 HEMPSTEAD TPKE |
WEST HEMPSTEAD,
NY
11552
|
|
Correspondent Contact |
WALTER LEDER |
Regulation Number | 868.5895
|
Classification Product Code |
|
Date Received | 03/04/1986 |
Decision Date | 07/10/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|