Cleared Traditional

AirKEE T900

K232642 · Healkee Medical Pte, Ltd. · General Hospital
May 2024
Decision
267d
Days
Class 2
Risk

About This 510(k) Submission

K232642 is an FDA 510(k) clearance for the AirKEE T900, a Purifier, Air, Ultraviolet, Medical (Class II — Special Controls, product code FRA), submitted by Healkee Medical Pte, Ltd. (Singapore, SG). The FDA issued a Cleared decision on May 23, 2024, 267 days after receiving the submission on August 30, 2023. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6500.

Submission Details

510(k) Number K232642 FDA.gov
FDA Decision Cleared SESE
Date Received August 30, 2023
Decision Date May 23, 2024
Days to Decision 267 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FRA — Purifier, Air, Ultraviolet, Medical
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.6500