K241758

Reprocessed RD SET Adt Pulse Oximeter Sensor (4000); Reprocessed RD SET Pdt Pulse Oximeter Sensor (4001); Reprocessed RD SET Inf Pulse Oximeter Sensor (4002); Reprocessed RD SET Adt Pulse Oximeter Sensor (4003)

510(k) number: K241758
Device name: Reprocessed RD SET Adt Pulse Oximeter Sensor (4000); Reprocessed RD SET Pdt Pulse Oximeter Sensor (4001); Reprocessed RD SET Inf Pulse Oximeter Sensor (4002); Reprocessed RD SET Adt Pulse Oximeter Sensor (4003)
Applicant: Stryker Sustainability Solutions AZ · US
Product code: NLF — Oximeter, Reprocessed
Decision date: 2024-10-22
Date received: 2024-06-20
Decision: Substantially Equivalent
Clearance type: Traditional
Advisory committee: Cardiovascular

PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain

Also available from FDA: K241758.pdf

Official FDA record: K241758

Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.