510(k) K173696

TBL-ABI System by Ld Technology, LLC — Product Code JOM

K173696 is an FDA 510(k) premarket notification submitted by Ld Technology, LLC for the device "TBL-ABI System". The FDA issued a decision of Substantially Equivalent on December 19, 2017. The device falls under product code JOM (Plethysmograph, Photoelectric, Pneumatic Or Hydraulic), a Class II device regulated under 21 CFR 870.2780. Ld Technology, LLC has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 19, 2017
Date Received
December 1, 2017
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plethysmograph, Photoelectric, Pneumatic Or Hydraulic
Device Class
Class II
Regulation Number
870.2780
Review Panel
CV
Submission Type