Device Classification Name |
analyzer, gas, oxygen, gaseous-phase
|
510(k) Number |
K221734 |
Device Name |
Maxtec MaxO2 ME+p |
Applicant |
Maxtec, LLC |
2305 South 1070 West |
Salt Lake City,
UT
84119
|
|
Applicant Contact |
Sidra Hankins |
Correspondent |
ProMedic Consulting LLC |
131 Bay Point Dr NE |
Saint Petersburg,
FL
33704
|
|
Correspondent Contact |
Paul Dryden |
Regulation Number | 868.1720
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/15/2022 |
Decision Date | 04/01/2023 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|