Device Classification Name |
mixer, breathing gases, anesthesia inhalation
|
510(k) Number |
K113232 |
Device Name |
MAXMIXING BLOCK |
Applicant |
MAXTEC, INC. |
6526 SOUTH COTTONWOOD ST. |
SALT LAKE CITY,
UT
84107
|
|
Applicant Contact |
TAMMY LAVERY |
Correspondent |
MAXTEC, INC. |
6526 SOUTH COTTONWOOD ST. |
SALT LAKE CITY,
UT
84107
|
|
Correspondent Contact |
TAMMY LAVERY |
Regulation Number | 868.5330
|
Classification Product Code |
|
Date Received | 11/02/2011 |
Decision Date | 03/01/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|