510(k) K210279
K210279 is an FDA 510(k) premarket notification submitted by Enbio Group AG for the device "Enbio S". The FDA issued a decision of Substantially Equivalent on October 29, 2021. The device falls under product code FLE (Sterilizer, Steam), a Class II device regulated under 21 CFR 880.6880. Enbio Group AG has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 29, 2021
- Date Received
- February 1, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Sterilizer, Steam
- Device Class
- Class II
- Regulation Number
- 880.6880
- Review Panel
- HO
- Submission Type