BIOFLEX LD-175 AND LD-1200 TREATMENT HEADS

Lamp, Infrared, Therapeutic Heating

MEDITECH INTERNATIONAL, INC.

The following data is part of a premarket notification filed by Meditech International, Inc. with the FDA for Bioflex Ld-175 And Ld-1200 Treatment Heads.

Pre-market Notification Details

Device IDK041885
510k NumberK041885
Device Name:BIOFLEX LD-175 AND LD-1200 TREATMENT HEADS
ClassificationLamp, Infrared, Therapeutic Heating
Applicant MEDITECH INTERNATIONAL, INC. 1151 HOPE ST. Stamford,  CT  06907
ContactRichard Keen
CorrespondentRichard Keen
MEDITECH INTERNATIONAL, INC. 1151 HOPE ST. Stamford,  CT  06907
Product CodeILY  
CFR Regulation Number890.5500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-07-12
Decision Date2005-02-24
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
B271LDI2000 K041885 000
B271LDI200P0 K041885 000

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