NICU V'02

Computer, Oxygen-uptake

COSMED Nordic ApS

The following data is part of a premarket notification filed by Cosmed Nordic Aps with the FDA for Nicu V'02.

Pre-market Notification Details

Device IDK190561
510k NumberK190561
Device Name:NICU V'02
ClassificationComputer, Oxygen-uptake
Applicant COSMED Nordic ApS Lucernemarken 23 Odense,  DK Dk-5260
ContactPeter Clemensen
CorrespondentH. Carl Jenkins
Wood Burditt Group 10 E. Scranton Ave., Ste. 201 Lake Bluff,  IL  60044
Product CodeBZL  
CFR Regulation Number868.1730 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-03-05
Decision Date2020-09-04

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.