FDA 510(k), K182073, BcSs-PICNI-2000 Sensor

FDA 510(k), K182073, BcSs-PICNI-2000 Sensor

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510(K) Number: K182073
Device Name: BcSs-PICNI-2000 Sensor
Manufacturer: Arnaldo Betta
Device Classification Name: Device, Monitoring, Intracranial Pressure
Regulation Number: GWM
Classification Product Code: KXA
Date Received: 08/01/2018
Decision Date: 10/17/2019
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Neurology

  • Total Pages: 1,294
  • Fully Redacted Pages: 174
  • Content Pages: 1,120 (total pages minus fully redacted pages)

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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