BABI PLUS INFANT NASAL CANNULA SYSTEM

Ventilator, Non-continuous (respirator)

A PLUS MEDICAL

The following data is part of a premarket notification filed by A Plus Medical with the FDA for Babi Plus Infant Nasal Cannula System.

Pre-market Notification Details

Device IDK110471
510k NumberK110471
Device Name:BABI PLUS INFANT NASAL CANNULA SYSTEM
ClassificationVentilator, Non-continuous (respirator)
Applicant A PLUS MEDICAL 5431 AVENIDA ENCINAS SUITE G Carlsbad,  CA  92008
ContactThomas C Loescher
CorrespondentThomas C Loescher
A PLUS MEDICAL 5431 AVENIDA ENCINAS SUITE G Carlsbad,  CA  92008
Product CodeBZD  
CFR Regulation Number868.5905 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-02-18
Decision Date2011-10-07
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
44710810117525 K110471 000

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