Cleared Traditional

NICU V'02

K190561 · Cosmed Nordic Aps · Anesthesiology
Sep 2020
Decision
549d
Days
Class 2
Risk

About This 510(k) Submission

K190561 is an FDA 510(k) clearance for the NICU V'02, a Computer, Oxygen-uptake (Class II — Special Controls, product code BZL), submitted by Cosmed Nordic Aps (Odense, DK). The FDA issued a Cleared decision on September 4, 2020, 549 days after receiving the submission on March 5, 2019. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1730.

Submission Details

510(k) Number K190561 FDA.gov
FDA Decision Cleared SESE
Date Received March 05, 2019
Decision Date September 04, 2020
Days to Decision 549 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BZL — Computer, Oxygen-uptake
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.1730