Device Classification Name |
ventilator, non-continuous (respirator)
|
510(k) Number |
K000215 |
Device Name |
SWIVEL ELBOW |
Applicant |
ENGINEERED MEDICAL SYSTEMS |
2055 EXECUTIVE DR. |
INDIANAPOLIS,
IN
46241
|
|
Applicant Contact |
BONNIE HOLLY |
Correspondent |
ENGINEERED MEDICAL SYSTEMS |
2055 EXECUTIVE DR. |
INDIANAPOLIS,
IN
46241
|
|
Correspondent Contact |
BONNIE HOLLY |
Regulation Number | 868.5905
|
Classification Product Code |
|
Date Received | 01/24/2000 |
Decision Date | 05/26/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|