510(k) K160956

LD-Oxi system by Ld Technology, LLC — Product Code MWI

K160956 is an FDA 510(k) premarket notification submitted by Ld Technology, LLC for the device "LD-Oxi system". The FDA issued a decision of Substantially Equivalent on July 6, 2016. The device falls under product code MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)), a Class II device regulated under 21 CFR 870.2300. Ld Technology, LLC has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 6, 2016
Date Received
April 5, 2016
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Device Class
Class II
Regulation Number
870.2300
Review Panel
CV
Submission Type