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FDA 510(k)

MODEL BION 2/TYPE 90 ROOM IONIZER

K-Number: K851358 · 1985-07-01

ApplicantMedicor USA , Ltd.
Decision Date1985-07-01
Product CodeFRF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MODEL BION 2/TYPE 90 ROOM IONIZER is the device name listed in this FDA 510(k) record. The listed applicant is Medicor USA , Ltd.. It received FDA 510(k) clearance on 1985-07-01 under 510(k) number K851358. 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 MODEL BION 2/TYPE 90 ROOM IONIZER?

MODEL BION 2/TYPE 90 ROOM IONIZER is a medical device that received FDA 510(k) clearance on 1985-07-01. The listed applicant is Medicor USA , Ltd.. The 510(k) number is K851358.

When did MODEL BION 2/TYPE 90 ROOM IONIZER receive FDA 510(k) clearance?

MODEL BION 2/TYPE 90 ROOM IONIZER received FDA 510(k) clearance on 1985-07-01, under 510(k) number K851358.

Who is the listed applicant for MODEL BION 2/TYPE 90 ROOM IONIZER?

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

What is the FDA product code for MODEL BION 2/TYPE 90 ROOM IONIZER?

The FDA product code for MODEL BION 2/TYPE 90 ROOM IONIZER is FRF.

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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.

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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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