inforMED
CCEClass II

Analyzer, Gas, Oxygen, Partial Pressure, Blood-phase, Indwelling

Anesthesiology · 21 CFR 868.1200

MDR events252All time
Recalls0All time
Registered firms0Currently listed
510(k) clearances23All time

Recent MDR events

252 adverse event reports on file

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Event type breakdown

Other143
Malfunction104
Injury3
Unspecified1
Death1

Most-reported manufacturers

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Diametrics Medical, Ltd.85Diametrics Medical Ltd.70Diametrics Medical Ltd42Radiometer Medical Aps28Diametrics Medical Limited10Biomedical Sensors Ltd5Optical Sensors, Inc.3Radiometer Medical A/s3

Recalls

0 recall events for this product code

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No recalls on file for this product code.

Registered firms

0 firms currently registered for this product code

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No registered firms found for this product code.

510(k) clearances

23 clearances for this product code

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