BIOFLEX PRESCRIPTION SYSTEM AND RELATED 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 Prescription System And Related Treatment Heads.

Pre-market Notification Details

Device IDK051875
510k NumberK051875
Device Name:BIOFLEX PRESCRIPTION SYSTEM AND RELATED 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 Received2005-07-11
Decision Date2006-03-13
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
B271SLD1800 K051875 000
B271SLD1200 K051875 000
B271CUP0 K051875 000
B271CU0 K051875 000
B271LSB48900 K051875 000
B271LSB32700 K051875 000
B271ART1800 K051875 000

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