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FDA 510(k)

DEFENDER ROOM AIR CLEANER, MODEL RAC-3000A

K-Number: K002692 · 2000-11-17

ApplicantHmi Industries, Inc.
Decision Date2000-11-17
Product CodeFRF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

DEFENDER ROOM AIR CLEANER, MODEL RAC-3000A is the device name listed in this FDA 510(k) record. The listed applicant is Hmi Industries, Inc.. It received FDA 510(k) clearance on 2000-11-17 under 510(k) number K002692. The device is classified under product code FRF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DEFENDER ROOM AIR CLEANER, MODEL RAC-3000A?

DEFENDER ROOM AIR CLEANER, MODEL RAC-3000A is a medical device that received FDA 510(k) clearance on 2000-11-17. The listed applicant is Hmi Industries, Inc.. The 510(k) number is K002692.

When did DEFENDER ROOM AIR CLEANER, MODEL RAC-3000A receive FDA 510(k) clearance?

DEFENDER ROOM AIR CLEANER, MODEL RAC-3000A received FDA 510(k) clearance on 2000-11-17, under 510(k) number K002692.

Who is the listed applicant for DEFENDER ROOM AIR CLEANER, MODEL RAC-3000A?

The FDA 510(k) record lists Hmi Industries, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DEFENDER ROOM AIR CLEANER, MODEL RAC-3000A?

The FDA product code for DEFENDER ROOM AIR CLEANER, MODEL RAC-3000A is FRF.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Hmi Industries, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K010616DEFENDER ROOM AIR CLEANER, MODEL RAC-4000AK921797PRECI-JET 50

Related Devices (Code: FRF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251872Biomoneta Avata RxBiomoneta Research Private LimitedK242102CerroZone MiniCerrozone, LLCK240696Airdog X8 Air Purifier (KJ800F-X8)Suzhou Beiang Smart Technology Co., Ltd.K223835MA-40, MA-112Medify Air, LLCK222416RIA SafeguardRia Tech Co., Ltd.K211507Airdog X5 Recirculating Air Cleaner (model KJ300F-X5)Beiang Air Tech , Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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