Device Classification Name |
Apparatus, Nitric Oxide Delivery
|
510(k) Number |
K120216 |
FOIA Releasable 510(k) |
K120216
|
Device Name |
GENOSYL MV-1000 |
Applicant |
GENO LLC |
2941 OXBOW CIRCLE |
COCOA,
FL
32926
|
|
Applicant Contact |
PAUL DRYDEN |
Correspondent |
GENO LLC |
2941 OXBOW CIRCLE |
COCOA,
FL
32926
|
|
Correspondent Contact |
PAUL DRYDEN |
Regulation Number | 868.5165
|
Classification Product Code |
|
Date Received | 01/24/2012 |
Decision Date | 05/16/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|