510(k) K170304
K170304 is an FDA 510(k) premarket notification submitted by Astell Scientific Limited for the device "Astell UMB 220, UMB 230, UMB 240 Autoclaves/sterilizers". The FDA issued a decision of Substantially Equivalent on Mar 2, 2018. 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
- Mar 2, 2018
- Date Received
- Jan 31, 2017
- 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
- 510(k)