inforMED
PGJClass II

Oximeter, Wellness

Cardiovascular · 21 CFR 870.2700

Pulse oximeter intended for wellness use.

MDR events2All time
Recalls0All time
Registered firms37Currently listed
510(k) clearances0All time

Event type breakdown

Injury1
Malfunction1

Most-reported manufacturers

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Product problems

Reported product problem codes, most common first

Computer Software Problem1
Patient-Device Incompatibility1

Trend for “Computer Software Problem

No history to chart.

Recalls

0 recall events for this product code

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No recalls on file for this product code.

510(k) clearances

0 clearances for this product code

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No 510(k) clearances on file for this product code.