MOBILE PAK, MODEL DC

Generator, Oxygen, Portable

INTL. BIOMEDICAL CONCEPTS, INC.

The following data is part of a premarket notification filed by Intl. Biomedical Concepts, Inc. with the FDA for Mobile Pak, Model Dc.

Pre-market Notification Details

Device IDK880262
510k NumberK880262
Device Name:MOBILE PAK, MODEL DC
ClassificationGenerator, Oxygen, Portable
Applicant INTL. BIOMEDICAL CONCEPTS, INC. 2955 SOUTH TEJON Englewood,  CO  80110
ContactGeorgi, Iii
CorrespondentGeorgi, Iii
INTL. BIOMEDICAL CONCEPTS, INC. 2955 SOUTH TEJON Englewood,  CO  80110
Product CodeCAW  
CFR Regulation Number868.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-01-22
Decision Date1988-02-12

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