Device Classification Name |
ventilator, continuous, facility use
|
510(k) Number |
K863155 |
Device Name |
UNIVERSAL JET VENTILATOR MODEL AMS-1000 |
Applicant |
ACUTRONIC MEDICAL SYSTEMS AG |
KREUZSTRASSE 100 |
JONA-RAPPER SWRIL,
CH
8645
|
|
Applicant Contact |
AJAI SINH |
Correspondent |
ACUTRONIC MEDICAL SYSTEMS AG |
KREUZSTRASSE 100 |
JONA-RAPPER SWRIL,
CH
8645
|
|
Correspondent Contact |
AJAI SINH |
Regulation Number | 868.5895
|
Classification Product Code |
|
Date Received | 08/15/1986 |
Decision Date | 09/28/1987 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|