Device Classification Name |
Mask, Gas, Anesthetic
|
510(k) Number |
K163277 |
Device Name |
SuperNO2VA Device |
Applicant |
Revolutionary Medical Devices, Inc. |
4090 E. Bujia Primera |
Tucson,
AZ
85718
|
|
Applicant Contact |
David M. Kane |
Correspondent |
ProMedic, LLC |
24301 Woodsage Dr. |
Bonita Springs,
FL
34134
|
|
Correspondent Contact |
Paul Dryden |
Regulation Number | 868.5550
|
Classification Product Code |
|
Date Received | 11/21/2016 |
Decision Date | 10/13/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|