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FDA 510(k)

Fibroid Mapping Reviewer Application (FMRA)

K-Number: K222683 · 2023-07-17

ApplicantNesa Medtech Private Limited
Decision Date2023-07-17
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Fibroid Mapping Reviewer Application (FMRA) is a medical device manufactured by Nesa Medtech Private Limited. It received FDA 510(k) clearance on 2023-07-17 under approval number K222683. 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 Fibroid Mapping Reviewer Application (FMRA)?

Fibroid Mapping Reviewer Application (FMRA) is a medical device that received FDA 510(k) clearance on 2023-07-17. It is manufactured by Nesa Medtech Private Limited. The 510(k) number is K222683.

When was Fibroid Mapping Reviewer Application (FMRA) approved by the FDA?

Fibroid Mapping Reviewer Application (FMRA) received FDA 510(k) clearance on 2023-07-17, under approval number K222683.

What company makes Fibroid Mapping Reviewer Application (FMRA)?

Fibroid Mapping Reviewer Application (FMRA) is manufactured by Nesa Medtech Private Limited.

What is the FDA product code for Fibroid Mapping Reviewer Application (FMRA)?

The FDA product code for Fibroid Mapping Reviewer Application (FMRA) is LLZ.

Related Clinical Trials

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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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