510(k) K130172
K130172 is an FDA 510(k) premarket notification submitted by Belimed, Inc. for the device "BELIMED STEAM STERILIZER MST-V". The FDA issued a decision of Substantially Equivalent on September 23, 2013. The device falls under product code FLE (Sterilizer, Steam), a Class II device regulated under 21 CFR 880.6880. Belimed, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 23, 2013
- Date Received
- January 24, 2013
- 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