Transformair Indoor Air Purifier— 510(k) K161468

Name: FDA 510(k) clearance K161468
Creator: U.S. Food and Drug Administration
Published: 2017-02-08

Substantially Equivalent

Transformair, LLC

FDA 510(k) clearance K161468 for Transformair Indoor Air Purifier, Substantially Equivalent on 2017-02-08. Applicant: Transformair, LLC. Device class: 2.

Clearance details

Applicant: Transformair, LLC
Product code: Code FRA
Device class: Class 2
Regulation: 21 CFR 880.6500
Advisory panel: General Hospital
Date received: 2016-05-27
Decision date: 2017-02-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tampa, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FRA

view all

K252128 — Zener® (model ZEN-001-B1)2025-09-15
K241140 — ViroZap Indoor Air Purifier, In Duct Model 10082024-08-01
K232642 — AirKEE T9002024-05-23
K232933 — AirKEE P9002024-05-16
K232645 — Airgle Room Air Purifier2024-02-16

Data sourced from openFDA. This site is unofficial and independent of the FDA.