510(k) DEN150008
- Device
- INVOcell
- Applicant
- Invo Bioscience
- 510(k) number
- DEN150008
- Product code
- OYO
- Decision
- Unknown (DENG)
- Decision date
- 2015-11-02
- Date received
- 2015-02-23
- Regulation
- 884.6165
- Classification name
- Culture, Intravaginal, Assisted Reproduction
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Kathleen Karloff
- Address
- 407 R Mystic Ave. Medford MA US 02155 02155
FDA Registration Numbers#
- 3008101047
- 1225492
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code OYO#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K222932 | INVOcell Intravaginal Culture System | Invo Bioscience | 2023-06-22 |