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510(k) K242931

HFT750U by Mekics Co., Ltd. — Product Code MNT

K242931 is an FDA 510(k) premarket notification submitted by Mekics Co., Ltd. for the device "HFT750U". The FDA issued a decision of Substantially Equivalent on May 15, 2025. The device falls under product code MNT (Sv70 Ventilator), a Class II device regulated under 21 CFR 868.5895.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 15, 2025
Date Received
September 25, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sv70 Ventilator
Device Class
Class II
Regulation Number
868.5895
Review Panel
AN
Submission Type

Other clearances for product code MNT

  • K252182 — SV70 Ventilator (SV70) (April 6, 2026)
  • K240779 — Vivo 3 (December 13, 2024)
  • K233643 — F&P Airvo 3 NIV (PT311US) (August 9, 2024)
  • K230173 — Servo-air Lite Ventilator System (July 6, 2023)
  • K213521 — Nihon Kohden NKV-330 Ventilator System (July 1, 2022)
  • K191624 — F&P Nivairo RT047 Vented Hospital Full Face Mask, Anti-Asphyxiation Valve Versio (March 9, 2020)
  • K170367 — Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Large (August 24, 2017)
  • K122715 — STELLAR 150 (June 17, 2013)
  • K121623 — BIPAP A 40 VENTILATORY SUPPORT SYSTEM (December 14, 2012)
  • K113640 — STELLAR 150 (April 5, 2012)

FDA data resources