Device Classification Name |
Tube, Tracheal (W/Wo Connector)
|
510(k) Number |
K933398 |
Device Name |
BIVONA ILLUMINATED ENDOTRACHEAL TUBE |
Applicant |
BIVONA MEDICAL TECHNOLOGIES |
5700 WEST 23RD AVE. |
GARY,
IN
46406
|
|
Applicant Contact |
HARRY M KAUFMAN |
Correspondent |
BIVONA MEDICAL TECHNOLOGIES |
5700 WEST 23RD AVE. |
GARY,
IN
46406
|
|
Correspondent Contact |
HARRY M KAUFMAN |
Regulation Number | 868.5730
|
Classification Product Code |
|
Date Received | 07/12/1993 |
Decision Date | 10/06/1993 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|