| Device Classification Name |
Analyzer, Gas, Oxygen, Gaseous-Phase
|
|---|
| 510(k) Number |
K112402 |
|---|
| Device Name |
ULTRAMAXO2 OXYGEN ANALYER |
|---|
| Applicant |
| Maxtec, LLC |
| 6526 Cottonwood St. # 300 |
|
Salt Lake City,
UT
84107
|
|
| Applicant Contact |
TAMMY LAVERY |
| Correspondent |
| Maxtec, LLC |
| 6526 Cottonwood St. # 300 |
|
Salt Lake City,
UT
84107
|
|
| Correspondent Contact |
TAMMY LAVERY |
| Regulation Number | 868.1720 |
|---|
| Classification Product Code |
|
|---|
| Date Received | 08/22/2011 |
|---|
| Decision Date | 12/14/2011 |
|---|
| Decision |
Substantially Equivalent
(SESE) |
|---|
| Regulation Medical Specialty |
Anesthesiology
|
|---|
| 510k Review Panel |
Anesthesiology
|
|---|
| Summary |
Summary
|
| Type |
Abbreviated
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Combination Product |
No
|
|---|
Predetermined Change
Control Plan Authorized |
No
|
|---|