FDA 510(k), K203086, X-PLO2R

FDA 510(k), K203086, X-PLO2R

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510(K) Number: K203086
Device Name: X-PLO2R
Manufacturer: Belluscura LLC
Device Classification Name: generator, oxygen, portable
Regulation Number: 868.5440
Classification Product Code: CAW
Date Received: 10/13/2020
Decision Date: 03/02/2021
Regulation Medical Specialty: Anesthesiology

Total pages: 2,477
Fully redacted pages: 2,267
Content pages: 210

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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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