FDA 510(k), K033448, ELECTRO-OPTICAL AIR STERILIZER WITH IONIZER

FDA 510(k), K033448, ELECTRO-OPTICAL AIR STERILIZER WITH IONIZER

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510(K) Number: K033448
Device Name: ELECTRO-OPTICAL AIR STERILIZER WITH IONIZER
Manufacturer:
Device Classification Name: Purifier, Air, Ultraviolet, Medical
Regulation Number: 880.6500
Classification Product Code: FRA
Date Received: 10/29/2003
Decision Date: 07/12/2004
Regulation Medical Specialty: General Hospital

PLEASE NOTE: Most 510(k)s obtained through FOIA are heavily redacted, often omitting sections related to testing, software, manufacturing, and other technical data. Please be sure to review the total pages, redacted pages, and content pages listed in the description to get a sense of how much of the document is redacted. As the FDA FOIA office explains: “We HEAVILY REDACT the majority of the following portions of 510(k) filings: testing data, technical data, lab reports, manufacturing information, vendor information, substantive discussions regarding deficiencies or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.” If you’d like more details about a specific document before purchasing, please contact us at info@foiadocs.com.

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