FDA 510(k), K052396, OXYSURE PORTABLE OXYGEN GENERATOR, MODEL 615

FDA 510(k), K052396, OXYSURE PORTABLE OXYGEN GENERATOR, MODEL 615

Regular price $89.00 USD
Regular price Sale price $89.00 USD
Sale Sold out
510(K) Number: K052396
Device Name: OXYSURE PORTABLE OXYGEN GENERATOR, MODEL 615
Manufacturer:
Device Classification Name: Generator, Oxygen, Portable
Regulation Number: 868.5440
Classification Product Code: CAW
Date Received: 08/31/2005
Decision Date: 12/09/2005
Regulation Medical Specialty: Anesthesiology

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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

View full details