Device Classification Name |
analyzer, gas, oxygen, gaseous-phase
|
510(k) Number |
K173807 |
Device Name |
Accu O2 Oxygen Analyzer |
Applicant |
Precision Medical Inc. |
300 Held Drive |
Northampton,
PA
18067
|
|
Applicant Contact |
James Parker |
Correspondent |
Precision Medical Inc. |
300 Held Drive |
Northampton,
PA
18067
|
|
Correspondent Contact |
James Parker |
Regulation Number | 868.1720
|
Classification Product Code |
|
Date Received | 12/15/2017 |
Decision Date | 05/02/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|