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FDA 510(k)

Nova Max Creat eGFR Monitoring System

K-Number: K251281 · 2026-01-21

ApplicantNova Biomedical Corporation
Decision Date2026-01-21
Product CodeSHB
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Nova Max Creat eGFR Monitoring System is a medical device manufactured by Nova Biomedical Corporation. It received FDA 510(k) clearance on 2026-01-21 under approval number K251281. The device is classified under product code SHB. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Nova Max Creat eGFR Monitoring System?

Nova Max Creat eGFR Monitoring System is a medical device that received FDA 510(k) clearance on 2026-01-21. It is manufactured by Nova Biomedical Corporation. The 510(k) number is K251281.

When was Nova Max Creat eGFR Monitoring System approved by the FDA?

Nova Max Creat eGFR Monitoring System received FDA 510(k) clearance on 2026-01-21, under approval number K251281.

What company makes Nova Max Creat eGFR Monitoring System?

Nova Max Creat eGFR Monitoring System is manufactured by Nova Biomedical Corporation.

What is the FDA product code for Nova Max Creat eGFR Monitoring System?

The FDA product code for Nova Max Creat eGFR Monitoring System is SHB.

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Other Devices by Nova Biomedical Corporation

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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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