FDA 510(k), K131252, PURITAN BENNETT 980 SERIES VENTILATOR SYSTEM

FDA 510(k), K131252, PURITAN BENNETT 980 SERIES VENTILATOR SYSTEM

Regular price $89.00 USD
Regular price Sale price $89.00 USD
Sale Sold out
510(K) Number: K131252
Device Name: PURITAN BENNETT 980 SERIES VENTILATOR SYSTEM
Manufacturer:
Device Classification Name: Ventilator, Continuous, Facility Use
Regulation Number: 868.5895
Classification Product Code: CBK
Date Received: 05/02/2013
Decision Date: 02/24/2014
Regulation Medical Specialty: Anesthesiology

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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