TBL-ABI System

Plethysmograph, Photoelectric, Pneumatic Or Hydraulic

LD Technology LLC

The following data is part of a premarket notification filed by Ld Technology Llc with the FDA for Tbl-abi System.

Pre-market Notification Details

Device IDK173696
510k NumberK173696
Device Name:TBL-ABI System
ClassificationPlethysmograph, Photoelectric, Pneumatic Or Hydraulic
Applicant LD Technology LLC 100 N. Biscayne Blvd Suite 502 Miami,  FL  33132
ContactAlbert Maarek
CorrespondentAlbert Maarek
LD Technology LLC 100 N. Biscayne Blvd Suite 502 Miami,  FL  33132
Product CodeJOM  
CFR Regulation Number870.2780 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-12-01
Decision Date2017-12-19
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
B322C0011 K173696 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.