The following data is part of a premarket notification filed by Geno Llc with the FDA for Genosyl Mv-1000.
| Device ID | K120216 |
| 510k Number | K120216 |
| Device Name: | GENOSYL MV-1000 |
| Classification | Apparatus, Nitric Oxide Delivery |
| Applicant | GENO LLC 2941 OXBOW CIRCLE Cocoa, FL 32926 |
| Contact | Paul Dryden |
| Correspondent | Paul Dryden GENO LLC 2941 OXBOW CIRCLE Cocoa, FL 32926 |
| Product Code | MRN |
| CFR Regulation Number | 868.5165 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-01-24 |
| Decision Date | 2012-05-16 |
| Summary: | summary |