510(k) K214057
K214057 is an FDA 510(k) premarket notification submitted by Scican , Ltd. for the device "STATIM 6000B Vacuum Autoclave". The FDA issued a decision of Substantially Equivalent on March 31, 2022. The device falls under product code FLE (Sterilizer, Steam), a Class II device regulated under 21 CFR 880.6880. Scican , Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 31, 2022
- Date Received
- December 27, 2021
- Clearance Type
- Abbreviated
- 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