AVIATOR TRANSPORT INCUBATOR

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.

Pre-market Notification Details

Device IDK081399
510k NumberK081399
Device Name:AVIATOR TRANSPORT INCUBATOR
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 Received2008-05-19
Decision Date2008-06-06

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00865648000306 K081399 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.