510(k) K103126

TROPHON CHEMICAL INDICATOR by Nanosonics Limited — Product Code JOJ

K103126 is an FDA 510(k) premarket notification submitted by Nanosonics Limited for the device "TROPHON CHEMICAL INDICATOR". The FDA issued a decision of Substantially Equivalent on Mar 3, 2011. The device falls under product code JOJ (Indicator, Physical/Chemical Sterilization Process), a Class II device regulated under 21 CFR 880.2800. Nanosonics Limited has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Mar 3, 2011
Date Received
Oct 22, 2010
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