INFANT INCUBATOR

Incubator, Neonatal

BISTOS CO., LTD.

The following data is part of a premarket notification filed by Bistos Co., Ltd. with the FDA for Infant Incubator.

Pre-market Notification Details

Device IDK132543
510k NumberK132543
Device Name:INFANT INCUBATOR
ClassificationIncubator, Neonatal
Applicant BISTOS CO., LTD. 27 NEW ENGLAND DRIVE Ramsey,  NJ  07446
ContactYoung Chi
CorrespondentYoung Chi
BISTOS CO., LTD. 27 NEW ENGLAND DRIVE Ramsey,  NJ  07446
Product CodeFMZ  
CFR Regulation Number880.5400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-08-13
Decision Date2014-07-03
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10887529000134 K132543 000

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