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)

1

Summaries archived here

1 (direct download)

510(k) clearances (all years, FDA)

27 (all years; only the last 3 years are listed here)

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.

1 summaries are archived here for direct download.