AVIATOR TRANSPORT INCUBATOR WITH MASIMO PULSEOX, AVIATOR TRANSPORT INCUBATOR WITH NELLCOR 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 Aviator Transport Incubator With Masimo Pulseox, Aviator Transport Incubator With Nellcor Pulseox.

Pre-market Notification Details

Device IDK103527
510k NumberK103527
Device Name:AVIATOR TRANSPORT INCUBATOR WITH MASIMO PULSEOX, AVIATOR TRANSPORT INCUBATOR WITH NELLCOR 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 Date2011-04-15
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00868406000006 K103527 000

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