FDA 510(k) K143094, QuantaFlo, by Semler Scientific, Inc.

FDA 510(k) K143094, QuantaFlo, by Semler Scientific, Inc.

Regular price $1,495.37 USD
Regular price Sale price $1,495.37 USD
Sale Sold out

Device Classification Name: Plethysmograph, Photoelectric, Pneumatic Or Hydraulic
510(k) Number: K143094
Device Name: QuantaFlo
Applicant: Semler Scientific, Inc.
Regulation Number: 870.278
Classification Product Code: JOM
Date Received: 10/28/2014
Decision Date: 03/05/2015
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
510k Review Panel: Cardiovascular

Total number of pages: 781
Fully redacted pages: 181
Content pages: 600

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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