510(k) K213293
K213293 is an FDA 510(k) premarket notification submitted by Vitromed Langenfeld for the device "V-HEPES PLUS". The FDA issued a decision of Substantially Equivalent on Sep 14, 2022. The device falls under product code MQL (Media, Reproductive), a Class II device regulated under 21 CFR 884.6180.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 14, 2022
- Date Received
- Oct 1, 2021
- 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
- 510(k)