FDA 510(k), K192415, Study Watch with Irregular Pulse Monitor
FDA 510(k), K192415, Study Watch with Irregular Pulse Monitor
510(K) Number: K192415
Device Name: Study Watch with Irregular Pulse Monitor
Manufacturer: Verily Life Sciences LLC
Device Classification Name: Transmitters And Receivers, Electrocardiograph, Telephone
Regulation Number: 870.2920
Classification Product Code: DXH
Date Received: 09/04/2019
Decision Date: 01/17/2020
Regulation Medical Specialty: Cardiovascular
191 pages (643 of 834 pages are fully redacted)
Couldn't load pickup availability
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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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