Device Classification Name |
ventilator, emergency, manual (resuscitator)
|
510(k) Number |
K012271 |
Device Name |
ACUTEVENTILATOR |
Applicant |
IMPOEX INTERNATIONAL, LTD. |
500 EAGLE WAY #18 |
LITTLE RIVER,
SC
29566
|
|
Applicant Contact |
SIVERT CLAESSON |
Correspondent |
IMPOEX INTERNATIONAL, LTD. |
500 EAGLE WAY #18 |
LITTLE RIVER,
SC
29566
|
|
Correspondent Contact |
SIVERT CLAESSON |
Regulation Number | 868.5915
|
Classification Product Code |
|
Date Received | 07/19/2001 |
Decision Date | 10/04/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|