510(k) K222606
K222606 is an FDA 510(k) premarket notification submitted by Vitromed GmbH for the device "V-HYADASE". The FDA issued a decision of Substantially Equivalent on May 26, 2023. The device falls under product code MQL (Media, Reproductive), a Class II device regulated under 21 CFR 884.6180. Vitromed GmbH has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 26, 2023
- Date Received
- August 29, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Media, Reproductive
- Device Class
- Class II
- Regulation Number
- 884.6180
- Review Panel
- OB
- Submission Type