510(k) K120216
K120216 is an FDA 510(k) premarket notification submitted by Geno, LLC for the device "GENOSYL MV-1000". The FDA issued a decision of Substantially Equivalent on May 16, 2012. The device falls under product code MRN (Apparatus, Nitric Oxide Delivery), a Class II device regulated under 21 CFR 868.5165.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 16, 2012
- Date Received
- January 24, 2012
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Apparatus, Nitric Oxide Delivery
- Device Class
- Class II
- Regulation Number
- 868.5165
- Review Panel
- AN
- Submission Type