NLF

Oximeter, Reprocessed

Product code: NLF
Device name: Oximeter, Reprocessed
Device class: Class 2
21 CFR: 21 CFR 870.2700
Medical specialty: Cardiovascular
Marketing pathway: 510(K)
Flag: Third-party review eligible
510(k) clearances (last 3 years): 27

FDA classification definition

same as DQA except reprocessed. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2024-10-22.

Number	Decision date	Applicant	Device name	Summary
K241758	2024-10-22	Stryker Sustainability Solutions	Reprocessed RD SET Adt Pulse Oximeter Sensor (4000)	PDF

1 summaries are archived here for direct download.

Official FDA classification page: NLF

Classification and pathway per current FDA publications. Data from openFDA (CC0).