Device Classification Name |
analyzer, gas, carbon-dioxide, gaseous-phase
|
510(k) Number |
K182362 |
Device Name |
MaxCap Ped and MaxCap Neo |
Applicant |
Maxtec, LLC |
2305 S 1070 W |
Salt Lake City,
UT
84119
|
|
Applicant Contact |
Tammy Lavery |
Correspondent |
Maxtec, LLC |
2305 S 1070 W |
Salt Lake City,
UT
84119
|
|
Correspondent Contact |
Paul Dryden |
Regulation Number | 868.1400
|
Classification Product Code |
|
Date Received | 08/30/2018 |
Decision Date | 05/23/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|