inforMED
PXHClass II

Thermometer Kit

General Hospital · 21 CFR 880.2910

This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

MDR events14All time
Recalls0All time
Registered firms16Currently listed
510(k) clearances0All time

Recent MDR events

14 adverse event reports on file

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Event type breakdown

Malfunction13
Injury1

Most-reported manufacturers

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Depuy Orthopaedics Inc Us8Depuy Ireland - 96166713American Screening Corporation1Hunan Honggao Electronic Technology Co., Ltd1Tornier Inc1

Recalls

0 recall events for this product code

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No recalls on file for this product code.

Registered firms

16 firms currently registered for this product code

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510(k) clearances

0 clearances for this product code

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