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FDA 510(k)

ICS 9400 ULTRAVIOLET AIR PURIFIER

K-Number: K934914 · 1994-04-13

ApplicantMedair, Inc.
Decision Date1994-04-13
Product CodeFRA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ICS 9400 ULTRAVIOLET AIR PURIFIER is the device name listed in this FDA 510(k) record. The listed applicant is Medair, Inc.. It received FDA 510(k) clearance on 1994-04-13 under 510(k) number K934914. The device is classified under product code FRA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ICS 9400 ULTRAVIOLET AIR PURIFIER?

ICS 9400 ULTRAVIOLET AIR PURIFIER is a medical device that received FDA 510(k) clearance on 1994-04-13. The listed applicant is Medair, Inc.. The 510(k) number is K934914.

When did ICS 9400 ULTRAVIOLET AIR PURIFIER receive FDA 510(k) clearance?

ICS 9400 ULTRAVIOLET AIR PURIFIER received FDA 510(k) clearance on 1994-04-13, under 510(k) number K934914.

Who is the listed applicant for ICS 9400 ULTRAVIOLET AIR PURIFIER?

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

What is the FDA product code for ICS 9400 ULTRAVIOLET AIR PURIFIER?

The FDA product code for ICS 9400 ULTRAVIOLET AIR PURIFIER is FRA.

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Related Devices (Code: FRA)

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.

K252128Zener® (model ZEN-001-B1)Uvx, Inc.K241140ViroZap Indoor Air Purifier, In Duct Model 1008Applied Photonix, LLCK232642AirKEE T900Healkee Medical Pte, Ltd.K232933AirKEE P900Healkee Medical Pte, Ltd.K232645Airgle Room Air PurifierAirgle CorporationK221540Synexis Sphere RxSynexis, LLC

Official Source

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

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