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)

HFT750U

K-Number: K242931 · 2025-05-15

ApplicantMekics Co., Ltd.
Decision Date2025-05-15
Product CodeMNT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

HFT750U is a medical device manufactured by Mekics Co., Ltd.. It received FDA 510(k) clearance on 2025-05-15 under approval number K242931. The device is classified under product code MNT. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HFT750U?

HFT750U is a medical device that received FDA 510(k) clearance on 2025-05-15. It is manufactured by Mekics Co., Ltd.. The 510(k) number is K242931.

When was HFT750U approved by the FDA?

HFT750U received FDA 510(k) clearance on 2025-05-15, under approval number K242931.

What company makes HFT750U?

HFT750U is manufactured by Mekics Co., Ltd..

What is the FDA product code for HFT750U?

The FDA product code for HFT750U is MNT.

Related Devices (Code: MNT)

K170367Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Large, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Medium, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Small, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Extra SmallFisher and Paykel Healthcare Limited K191624F&P Nivairo RT047 Vented Hospital Full Face Mask, Anti-Asphyxiation Valve VersionFisher & Paykel Healthcare Limited K213521Nihon Kohden NKV-330 Ventilator SystemNihon Kohden Orangemed, Inc. K230173Servo-air Lite Ventilator SystemMaquet Critical Care AB K240779Vivo 3Breas Medical AB K233643F&P Airvo 3 NIV (PT311US)Fisher & Paykel Healthcare, Ltd.

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.

↑