FDA Device Info: Records Regarding Philips Recalled Devices
FDA Device Info: Records Regarding Philips Recalled Devices
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All records relating to the 510(k) clearance of Philips recalled devices, including any recent amended applications seeking to "remediate" (i.e. repair and replace) the recalled devices, as well as any analyses performed by FDA or Philips and any information relating to FDA's decision to upgrade the recall from Class II to Class I. [REQ YEAR: 2021]
- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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