Hepa-Care Air Cleaner American Air Filter Air Filtration System (Hc800f +5 more) - Hc400c

FDA 510(k)

Class II (US FDA 510(k))

510(k) K984116

Identifiers

510(k) Number: K984116 FDA 510(k)
FDA Product Code: FRF FDA 510(k)
Models / Variants: Hc800f FDA 510(k)
Hfs800f FDA 510(k)
Hc800c FDA 510(k)
Hfs800c FDA 510(k)
Hc400c FDA 510(k)
Hfs400c FDA 510(k)

Classification

Device Class: Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 880.5045 FDA 510(k)
Regulation Number: 880.5045 FDA 510(k)
Advisory Committee: General Hospital FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

Hepa-Care Air Cleaner American Air Filter Air Filtration System (Hc800f +5 more) - Hc400c by Abatement Technologies, Inc. — Class II — FDA_510K — listed in…

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K984116	Class II	Active

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Manufacturer

Manufacturer: Abatement Technologies, Inc.

Sources (1)

FDA 510(k) K984116 24 fields · synced Jun 18, 2026