510(k) K141698

STERIZONE CHEMICAL INDICATOR by Tso3, Inc. — Product Code JOJ

K141698 is an FDA 510(k) premarket notification submitted by Tso3, Inc. for the device "STERIZONE CHEMICAL INDICATOR". The FDA issued a decision of Substantially Equivalent on December 17, 2014. The device falls under product code JOJ (Indicator, Physical/Chemical Sterilization Process), a Class II device regulated under 21 CFR 880.2800. Tso3, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 17, 2014
Date Received
June 24, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Indicator, Physical/Chemical Sterilization Process
Device Class
Class II
Regulation Number
880.2800
Review Panel
HO
Submission Type