FDA 510(k), K200599, Digital Thermometer

FDA 510(k), K200599, Digital Thermometer

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510(K) Number: K200599
Device Name: Digital Thermometer
Manufacturer: Joytech Healthcare Co., Ltd
Device Classification Name: Thermometer, Electronic, Clinical
Regulation Number: 880.2910
Classification Product Code: FLL
Date Received: 03/09/2020
Decision Date: 07/08/2020
Regulation Medical Specialty: General Hospital

175 pages (856 of 1,031 original pages are fully redacted)

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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