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
Source Documents
510(k) summary PDF not indicated by FDA
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|
| 00862190000358 | INVOcell Retention Device | INVO BIOSCIENCE, INC. | 2019-04-08 |
| 00862190000334 | INVOcell Culture Device | INVO BIOSCIENCE, INC. | 2017-05-09 |
| 00862190000341 | INVOcell Retention Device | INVO BIOSCIENCE, INC. | 2017-05-02 |
| 00862190000327 | INVOcell Holding Block | INVO BIOSCIENCE, INC. | 2016-09-23 |
| 00862190000310 | INVOcell Retention Device | INVO BIOSCIENCE, INC. | 2016-09-23 |
| 00862190000303 | INVOcell Culture Device | INVO BIOSCIENCE, INC. | 2016-09-23 |
Other 510(k) Records For Product Code OYO
| 510(k) | Device | Applicant | Decision date |
|---|
| K222932 | INVOcell Intravaginal Culture System | Invo Bioscience | 2023-06-22 |