NT MEDITENS PLUS, TYPE 290

Stimulator, Nerve, Transcutaneous, For Pain Relief

BIO-MEDICAL RESEARCH, LTD.

The following data is part of a premarket notification filed by Bio-medical Research, Ltd. with the FDA for Nt Meditens Plus, Type 290.

Pre-market Notification Details

Device IDK014020
510k NumberK014020
Device Name:NT MEDITENS PLUS, TYPE 290
ClassificationStimulator, Nerve, Transcutaneous, For Pain Relief
Applicant BIO-MEDICAL RESEARCH, LTD. PARKMORE BUSINESS PARK, West Galway,  IE
ContactMichelle Sawyer
CorrespondentMichelle Sawyer
BIO-MEDICAL RESEARCH, LTD. PARKMORE BUSINESS PARK, West Galway,  IE
Product CodeGZJ  
CFR Regulation Number882.5890 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-12-06
Decision Date2002-07-11
Summary:summary

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