510(k) K222932
- Device
- INVOcell Intravaginal Culture System
- Applicant
- Invo Bioscience
- 510(k) number
- K222932
- Product code
- OYO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-06-22
- Date received
- 2022-09-26
- Regulation
- 884.6165
- Classification name
- Culture, Intravaginal, Assisted Reproduction
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Steve Shum
- Address
- 5582 Broadcast Ct. Sarasota FL US 34240 34240
FDA Registration Numbers#
- 3008101047
- 1225492
Source Documents#
Other 510(k) Records For Product Code OYO#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| DEN150008 | INVOcell | Invo Bioscience | 2015-11-02 |