Device Classification Name |
analyzer, gas, carbon-dioxide, gaseous-phase
|
510(k) Number |
K172365 |
Device Name |
Panoramic Oxygen Mask (POM) |
Applicant |
Pom Medical, LLC |
1230 Madera Rd., Suite 5, Box 101 |
Simi Valley,
CA
92065
|
|
Applicant Contact |
Jeff Voss |
Correspondent |
Pom Medical, LLC c/o ProMedic, LLC |
131 Bay Point Dr NE |
St. Petersburg,
FL
33704
|
|
Correspondent Contact |
Paul Dryden |
Regulation Number | 868.1400
|
Classification Product Code |
|
Date Received | 08/04/2017 |
Decision Date | 04/19/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|