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FDA 510(k)

NICU V'02

K-Number: K190561 · 2020-09-04

ApplicantCosmed Nordic Aps
Decision Date2020-09-04
Product CodeBZL
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

NICU V'02 is a medical device manufactured by Cosmed Nordic Aps. It received FDA 510(k) clearance on 2020-09-04 under approval number K190561. The device is classified under product code BZL. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NICU V'02?

NICU V'02 is a medical device that received FDA 510(k) clearance on 2020-09-04. It is manufactured by Cosmed Nordic Aps. The 510(k) number is K190561.

When was NICU V'02 approved by the FDA?

NICU V'02 received FDA 510(k) clearance on 2020-09-04, under approval number K190561.

What company makes NICU V'02?

NICU V'02 is manufactured by Cosmed Nordic Aps.

What is the FDA product code for NICU V'02?

The FDA product code for NICU V'02 is BZL.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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