Device Classification Name |
Circuit, Breathing (W Connector, Adaptor, Y Piece)
|
510(k) Number |
K851530 |
Device Name |
4003 NON CONDUCTIVE ANESTHESIA CIRCUIT W/BREAT\GAS |
Applicant |
SIGMA MEDICAL, INC. |
5377 WEST 86TH STREET, BLDG. |
#8 |
INDIANAPOLIS,
IN
46268
|
|
Correspondent |
SIGMA MEDICAL, INC. |
5377 WEST 86TH STREET, BLDG. |
#8 |
INDIANAPOLIS,
IN
46268
|
|
Regulation Number | 868.5240
|
Classification Product Code |
|
Date Received | 04/16/1985 |
Decision Date | 04/25/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|