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FDA 510(k)

Nova Max Uric Acid Monitoring System

K-Number: K160990 · 2017-04-11

ApplicantNova Biomedical Corporation
Decision Date2017-04-11
Product CodePTC
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Nova Max Uric Acid Monitoring System is a medical device manufactured by Nova Biomedical Corporation. It received FDA 510(k) clearance on 2017-04-11 under approval number K160990. The device is classified under product code PTC. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Nova Max Uric Acid Monitoring System?

Nova Max Uric Acid Monitoring System is a medical device that received FDA 510(k) clearance on 2017-04-11. It is manufactured by Nova Biomedical Corporation. The 510(k) number is K160990.

When was Nova Max Uric Acid Monitoring System approved by the FDA?

Nova Max Uric Acid Monitoring System received FDA 510(k) clearance on 2017-04-11, under approval number K160990.

What company makes Nova Max Uric Acid Monitoring System?

Nova Max Uric Acid Monitoring System is manufactured by Nova Biomedical Corporation.

What is the FDA product code for Nova Max Uric Acid Monitoring System?

The FDA product code for Nova Max Uric Acid Monitoring System is PTC.

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Related PubMed Literature

PMID: 37181834 Methodology for Conducting Post-Marketing Surveillance of Software as a Medical Device Based on Artificial Intelligence Technologies. Sovremennye tekhnologii v meditsine (2022)

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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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