Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Cercare Medical Neurosuite

K-Number: K202793 · 2021-05-17

Decision Date2021-05-17
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Cercare Medical Neurosuite is a medical device manufactured by Cercare Medical Aps. It received FDA 510(k) clearance on 2021-05-17 under approval number K202793. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Cercare Medical Neurosuite?

Cercare Medical Neurosuite is a medical device that received FDA 510(k) clearance on 2021-05-17. It is manufactured by Cercare Medical Aps. The 510(k) number is K202793.

When was Cercare Medical Neurosuite approved by the FDA?

Cercare Medical Neurosuite received FDA 510(k) clearance on 2021-05-17, under approval number K202793.

What company makes Cercare Medical Neurosuite?

Cercare Medical Neurosuite is manufactured by Cercare Medical Aps.

What is the FDA product code for Cercare Medical Neurosuite?

The FDA product code for Cercare Medical Neurosuite is LLZ.

Related Devices (Code: LLZ)

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.