510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K190561Substantially Equivalent

NICU V'02

Cosmed Nordic ApS, Odense, DK / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K190561 is the FDA 510(k) clearance record for NICU V'02, a class II device, cleared for Cosmed Nordic Aps on under FDA product code BZL (Computer, Oxygen-Uptake). FDA records list one 510(k) clearance for Cosmed Nordic Aps. As of , FDA records show no recalls naming K190561.

Clearance record

Decision date
Received
(549 days to decision)
Product code
BZL Computer, Oxygen-Uptake
Regulation
21 CFR 868.1730
Device class
Class II
Review panel
Anesthesiology
Applicant
Cosmed Nordic Aps Lucernemarken 23, Odense, DK
510(k) summary
Summary PDF
Third party review
No

Clearances, product code BZL

Trailing 12 months

FDA records hold no clearances under product code BZL in the trailing twelve months.

FDA records show no clearances under product code BZL in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code BZL, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260