Device Classification Name |
mixer, breathing gases, anesthesia inhalation
|
510(k) Number |
K161718 |
Device Name |
MaxBlend 2, MaxBlend Lite |
Applicant |
Maxtec, LLC |
2305 South 1070 West |
Salt Lake City,
UT
84119
|
|
Applicant Contact |
Bruce Brierley |
Correspondent |
Maxtec, LLC |
2305 South 1070 West |
Salt Lake City,
UT
84119
|
|
Correspondent Contact |
Paul Dryden |
Regulation Number | 868.5330
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/22/2016 |
Decision Date | 10/27/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|