DEFENDER ROOM AIR CLEANER, MODEL RAC-4000A— 510(k) K010616

Name: FDA 510(k) clearance K010616
Creator: U.S. Food and Drug Administration
Published: 2001-03-28

Substantially Equivalent

Hmi Industries, Inc.

FDA 510(k) clearance K010616 for DEFENDER ROOM AIR CLEANER, MODEL RAC-4000A, Substantially Equivalent on 2001-03-28. Applicant: Hmi Industries, Inc.. Device class: 2.

Clearance details

Applicant: Hmi Industries, Inc.
Product code: Code FRF
Device class: Class 2
Regulation: 21 CFR 880.5045
Advisory panel: General Hospital
Date received: 2001-03-01
Decision date: 2001-03-28
Decision: Substantially Equivalent
Clearance type: Special
Location: Strongville, OH, US

Download summary PDF View on FDA.gov ↗

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