FDA 510(k), K212153, Biobeat Platform, BB-613WP Patch

FDA 510(k), K212153, Biobeat Platform, BB-613WP Patch

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510(K) Number: K212153
Device Name: Biobeat Platform, BB-613WP Patch
Manufacturer: BioBeat Technologies Ltd.
Device Classification Name: Oximeter
Regulation Number: 870.2700
Classification Product Code: DQA
Date Received: 07/09/2021
Decision Date: 03/25/2022
Regulation Medical Specialty: Cardiovascular

417 pages (1,393 of 1,810 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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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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