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FDA 510(k)

ELECTRO-OPTICAL AIR STERILIZER WITH IONIZER

K-Number: K033448 · 2004-07-12

ApplicantJohn Mfg., Ltd.
Decision Date2004-07-12
Product CodeFRA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ELECTRO-OPTICAL AIR STERILIZER WITH IONIZER is the device name listed in this FDA 510(k) record. The listed applicant is John Mfg., Ltd.. It received FDA 510(k) clearance on 2004-07-12 under 510(k) number K033448. 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 ELECTRO-OPTICAL AIR STERILIZER WITH IONIZER?

ELECTRO-OPTICAL AIR STERILIZER WITH IONIZER is a medical device that received FDA 510(k) clearance on 2004-07-12. The listed applicant is John Mfg., Ltd.. The 510(k) number is K033448.

When did ELECTRO-OPTICAL AIR STERILIZER WITH IONIZER receive FDA 510(k) clearance?

ELECTRO-OPTICAL AIR STERILIZER WITH IONIZER received FDA 510(k) clearance on 2004-07-12, under 510(k) number K033448.

Who is the listed applicant for ELECTRO-OPTICAL AIR STERILIZER WITH IONIZER?

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

What is the FDA product code for ELECTRO-OPTICAL AIR STERILIZER WITH IONIZER?

The FDA product code for ELECTRO-OPTICAL AIR STERILIZER WITH IONIZER 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.

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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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