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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 the device name listed in this FDA 510(k) record. The listed applicant is Nesa Medtech Private Limited. It received FDA 510(k) clearance on 2023-07-17 under 510(k) 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. The listed applicant is Nesa Medtech Private Limited. The 510(k) number is K222683.

When did Fibroid Mapping Reviewer Application (FMRA) receive FDA 510(k) clearance?

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

Who is the listed applicant for Fibroid Mapping Reviewer Application (FMRA)?

The FDA 510(k) record lists Nesa Medtech Private Limited as the applicant. This does not by itself establish the device manufacturer.

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 Devices (Code: LLZ)

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.

K262449AdvaViewADVAHEALTH SOLUTIONS, LLCK261916NeuroQuant PETCortechs Labs, Inc.K260936RadioViewAINeurocareai, Inc. (Dba Savelife.Ai)K260588Cleerly LABSCleerly, Inc.K262462TheraSphere 360™ Y-90 Management PlatformBoston Scientific CorporationK262143ImageGrid StreamVueCandelis, Inc.

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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