FDA 510(k), K182887, Masimo Rad-67 Pulse CO-Oximeter and Accessories

FDA 510(k), K182887, Masimo Rad-67 Pulse CO-Oximeter and Accessories

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510(K) Number: K182887
Device Name: Masimo Rad-67 Pulse CO-Oximeter and Accessories
Manufacturer: Masimo Corporation
Device Classification Name: Oximeter
Regulation Number: 870.2700
Classification Product Code: DQA
Date Received: 10/15/2018
Decision Date: 03/22/2019
Regulation Medical Specialty: Cardiovascular

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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