Cleared Traditional

AirKEE P900

K232933 · Healkee Medical Pte, Ltd. · General Hospital
May 2024
Decision
239d
Days
Class 2
Risk

About This 510(k) Submission

K232933 is an FDA 510(k) clearance for the AirKEE P900, 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 16, 2024, 239 days after receiving the submission on September 20, 2023. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6500.

Submission Details

510(k) Number K232933 FDA.gov
FDA Decision Cleared SESE
Date Received September 20, 2023
Decision Date May 16, 2024
Days to Decision 239 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