Cleared Traditional

Besmed Bacterial Filter and HMEF

K241339 · Besmed Health Business Corp · General Hospital
Nov 2024
Decision
185d
Days
Class 2
Risk

About This 510(k) Submission

K241339 is an FDA 510(k) clearance for the Besmed Bacterial Filter and HMEF, a Filter, Bacterial, Breathing-circuit (Class II — Special Controls, product code CAH), submitted by Besmed Health Business Corp (New Taipei City, TW). The FDA issued a Cleared decision on November 14, 2024, 185 days after receiving the submission on May 13, 2024. This device falls under the General Hospital review panel. Regulated under 21 CFR 868.5260.

Submission Details

510(k) Number K241339 FDA.gov
FDA Decision Cleared SESE
Date Received May 13, 2024
Decision Date November 14, 2024
Days to Decision 185 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code CAH — Filter, Bacterial, Breathing-circuit
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5260

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