NLF

27 FDA 510(k) clearances · Product code

FDA profile

Official device name

Oximeter, Reprocessed

Device class

Class II (moderate risk)

Regulation

21 CFR 870.2700

Medical specialty

Cardiovascular

Flags

Third-party review eligible

FDA 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).

Adverse events (MAUDE)

2008: 7 · 2009: 3 · 2012: 5 · 2026: 16
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.

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