DeviceClearance

HEPA-CARE AIR CLEANER AMERICAN AIR FILTER AIR FILTRATION SYSTEM MODELS HC800F, HFS800F, HC800C/ HFS800C, HC400C/HFS400C— 510(k) K984116

Substantially Equivalent

Abatement Technologies, Inc.

FDA 510(k) clearance K984116 for HEPA-CARE AIR CLEANER AMERICAN AIR FILTER AIR FILTRATION SYSTEM MODELS HC800F, HFS800F, HC800C/ HFS800C, HC400C/HFS400C, Substantially Equivalent on 1999-06-24. Applicant: Abatement Technologies, Inc.. Device class: 2.

Clearance details

Applicant
Abatement Technologies, Inc.
Product code
Code FRF
Device class
Class 2
Regulation
21 CFR 880.5045
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Duluth, GA, US
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