A750I TRANSPORT INCUBATOR WITH MASIMO PLUSEOX, A750I TRANSPORT INCUBATOR WITH NELLOR PULSEOX

Incubator, Neonatal Transport

INTERNATIONAL BIOMEDICAL, LTD.

The following data is part of a premarket notification filed by International Biomedical, Ltd. with the FDA for A750i Transport Incubator With Masimo Pluseox, A750i Transport Incubator With Nellor Pulseox.

Pre-market Notification Details

Device IDK103525
510k NumberK103525
Device Name:A750I TRANSPORT INCUBATOR WITH MASIMO PLUSEOX, A750I TRANSPORT INCUBATOR WITH NELLOR PULSEOX
ClassificationIncubator, Neonatal Transport
Applicant INTERNATIONAL BIOMEDICAL, LTD. 8508 CROSS PARK DR. Austin,  TX  78754
ContactAmy Pieper
CorrespondentAmy Pieper
INTERNATIONAL BIOMEDICAL, LTD. 8508 CROSS PARK DR. Austin,  TX  78754
Product CodeFPL  
CFR Regulation Number880.5410 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-12-01
Decision Date2011-05-11
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00868406000013 K103525 000

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