FDA 510(k), K040490, WELCH ALLYN SPOT ULTRA VITAL SIGNS DEVICE

FDA 510(k), K040490, WELCH ALLYN SPOT ULTRA VITAL SIGNS DEVICE

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510(K) Number: K040490
Device Name: WELCH ALLYN SPOT ULTRA VITAL SIGNS DEVICE
Manufacturer:
Device Classification Name: System, Measurement, Blood-Pressure, Non-Invasive
Regulation Number: 870.1130
Classification Product Code: DXN
Date Received: 02/26/2004
Decision Date: 08/18/2004
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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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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