510(k) DEN150008
DEN150008 is an FDA 510(k) premarket notification submitted by Invo Bioscience for the device "INVOcell". The FDA issued a decision of De Novo granted on Nov 2, 2015. The device falls under product code OYO (Culture, Intravaginal, Assisted Reproduction), a Class II device regulated under 21 CFR 884.6165. Invo Bioscience has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- DENG (De Novo granted)
- Decision Date
- Nov 2, 2015
- Date Received
- Feb 23, 2015
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Culture, Intravaginal, Assisted Reproduction
- Device Class
- Class II
- Regulation Number
- 884.6165
- Review Panel
- OB
- Submission Type
- 510(k)
Intravaginal culture of human gametes and embryos. To hold and maintain gametes and developing embryos over the duration of the intravaginal culture period.