Device Classification Name |
Circuit, Breathing (W Connector, Adaptor, Y Piece)
|
510(k) Number |
K925893 |
Device Name |
OEM MEDICAL ADULT ANESTHESIA BREATHING CIRCUIT |
Applicant |
OEM MEDICAL DIV. |
8741 LANDMARK RD. |
P.O. BOX 27604 |
RICHMOND,
VA
23228
|
|
Applicant Contact |
JERRY W SCHEIB |
Correspondent |
OEM MEDICAL DIV. |
8741 LANDMARK RD. |
P.O. BOX 27604 |
RICHMOND,
VA
23228
|
|
Correspondent Contact |
JERRY W SCHEIB |
Regulation Number | 868.5240 |
Classification Product Code |
|
Date Received | 11/17/1992 |
Decision Date | 03/12/1993 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|