Device Classification Name |
Circuit, Breathing (W Connector, Adaptor, Y Piece)
|
510(k) Number |
K844149 |
Device Name |
AMBU RUBEN CIRCLE ANESTHESIA SYSTEM |
Applicant |
AMBU, INC. |
7 OLD SHERMAN TURNPIKE |
DANBURY,
CT
06810
|
|
Applicant Contact |
ANDREA MOODY |
Correspondent |
AMBU, INC. |
7 OLD SHERMAN TURNPIKE |
DANBURY,
CT
06810
|
|
Correspondent Contact |
ANDREA MOODY |
Regulation Number | 868.5240
|
Classification Product Code |
|
Date Received | 10/24/1984 |
Decision Date | 11/15/1984 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|