510(k) K142454

STERRAD NX Sterilizer, STERRAD 100NX Sterilizer by Advanced Sterilization Products — Product Code MLR

K142454 is an FDA 510(k) premarket notification submitted by Advanced Sterilization Products for the device "STERRAD NX Sterilizer, STERRAD 100NX Sterilizer". The FDA issued a decision of Substantially Equivalent on April 3, 2015. The device falls under product code MLR (Sterilizer, Chemical), a Class II device regulated under 21 CFR 880.6860. Advanced Sterilization Products has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 3, 2015
Date Received
September 2, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sterilizer, Chemical
Device Class
Class II
Regulation Number
880.6860
Review Panel
HO
Submission Type