510(k) K153689
K153689 is an FDA 510(k) premarket notification submitted by Tso3, Inc. for the device "STERIZONE Sterilizer". The FDA issued a decision of Substantially Equivalent on June 30, 2016. The device falls under product code PJJ (Two Or More Sterilant Sterilizer), a Class II device regulated under 21 CFR 880.6860. Tso3, Inc. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 30, 2016
- Date Received
- December 23, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Two Or More Sterilant Sterilizer
- Device Class
- Class II
- Regulation Number
- 880.6860
- Review Panel
- HO
- Submission Type
Intended for use in terminal sterilization of cleaned, rinsed, and dried metal and non-metal reusable medical devices in health care facilities.