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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 the device name listed in this FDA 510(k) record. The listed applicant is Cosmed Nordic Aps. It received FDA 510(k) clearance on 2020-09-04 under 510(k) 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. The listed applicant is Cosmed Nordic Aps. The 510(k) number is K190561.

When did NICU V'02 receive FDA 510(k) clearance?

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

Who is the listed applicant for NICU V'02?

The FDA 510(k) record lists Cosmed Nordic Aps as the applicant. This does not by itself establish the device manufacturer.

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

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

Related Devices (Code: BZL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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

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