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FDA 510(k)

Fidmi Low Profile Enteral Feeding Device

K-Number: K191844 · 2019-09-30

ApplicantFidmi Medical, Ltd.
Decision Date2019-09-30
Product CodeKGC
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Fidmi Low Profile Enteral Feeding Device is a medical device manufactured by Fidmi Medical, Ltd.. It received FDA 510(k) clearance on 2019-09-30 under approval number K191844. The device is classified under product code KGC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Fidmi Low Profile Enteral Feeding Device?

Fidmi Low Profile Enteral Feeding Device is a medical device that received FDA 510(k) clearance on 2019-09-30. It is manufactured by Fidmi Medical, Ltd.. The 510(k) number is K191844.

When was Fidmi Low Profile Enteral Feeding Device approved by the FDA?

Fidmi Low Profile Enteral Feeding Device received FDA 510(k) clearance on 2019-09-30, under approval number K191844.

What company makes Fidmi Low Profile Enteral Feeding Device?

Fidmi Low Profile Enteral Feeding Device is manufactured by Fidmi Medical, Ltd..

What is the FDA product code for Fidmi Low Profile Enteral Feeding Device?

The FDA product code for Fidmi Low Profile Enteral Feeding Device is KGC.

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Related PubMed Literature

PMID: 42204020 A Minimal UDI-DICOM Mapping Profile and Validation Artifact for Medical-Device Imaging Workflows. Journal of imaging informatics in medicine (2026) PMID: 39707817 Physician-Patient Communication about Novel Drugs and High-Risk Medical Devices. Medical decision making : an international journal of the Society for Medical Decision Making (2025) PMID: 37209414 Adverse events associated with Aveir Journal of cardiovascular electrophysiology (2023) PMID: 36976820 Identification of predicate creep under the 510(k) process: A case study of a robotic surgical device. PloS one (2023)

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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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