510(k) K220102
K220102 is an FDA 510(k) premarket notification submitted by Shinva Medical Instrument Co., Ltd. for the device "MOST-T Autoclave". The FDA issued a decision of Substantially Equivalent on October 12, 2022. The device falls under product code FLE (Sterilizer, Steam), a Class II device regulated under 21 CFR 880.6880.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 12, 2022
- Date Received
- January 12, 2022
- 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