FDA 510(k), K142932, Deltex Medical KDP72 Doppler Probe

FDA 510(k), K142932, Deltex Medical KDP72 Doppler Probe

Regular price $969.46 USD
Regular price Sale price $969.46 USD
Sale Sold out

510(K) Number: K142932
Device Name: Deltex Medical KDP72 Doppler Probe
Manufacturer: DELTEX MEDICAL LIMITED
Device Classification Name: probe, blood-flow, extravascular
Regulation Number: 870.2120
Classification Product Code: DPT
Date Received: 10/09/2014
Decision Date: 01/22/2015
Regulation Medical Specialty: Cardiovascular

Total pages: 1,332
Fully redacted pages: 848
Content pages: 484

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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