Device Classification Name |
condenser, heat and moisture (artificial nose)
|
510(k) Number |
K953544 |
Device Name |
HUMID-VENT 2 LIGHT/HUMID-VENT 2 PORT LIGHT |
Applicant |
GIBECK, INC. |
10640 EAST 59TH ST. |
P.O. BOX 36430 |
INDIANAPOLIS,
IN
46236
|
|
Applicant Contact |
BRIAN GRIGSBY |
Correspondent |
GIBECK, INC. |
10640 EAST 59TH ST. |
P.O. BOX 36430 |
INDIANAPOLIS,
IN
46236
|
|
Correspondent Contact |
BRIAN GRIGSBY |
Regulation Number | 868.5375
|
Classification Product Code |
|
Date Received | 07/28/1995 |
Decision Date | 08/25/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|