Product code NLF

Device name

Oximeter, Reprocessed

Medical specialty

Cardiovascular

Device class

2

Regulation number

870.2700

Review panel

AN

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

Y

Summary malfunction reporting

Eligible

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).

Source

FDA openFDA device classification dataset