Name: Predicase
Price: 199 USD

K-number	K093795
Device name	ACTHERM INFRARED EAR THERMOMETER ACT 8000R SERIES AND ITS PROBE COVER MED ACCU2010
Applicant	Actherm, Inc.
Product code	FLL
Device class	Class II
Decision date	Mar 12, 2010
Decision	Substantially Equivalent
Regulation	880.2910

AI Summary

AI extraction for this record is queued and will appear within 24 hours. View full FDA record →

Source

View the full FDA submission: accessdata.fda.gov

Researching this as a predicate?

Want a transparent AI-ranking score, AI-discovered related predicates, ongoing safety and warning-letter monitoring, full predicate chain lineage, and a drafted SE rationale — all saved to your own project? That's what an account adds.

Start free trial →

ACTHERM INFRARED EAR THERMOMETER ACT 8000R SERIES AND ITS PROBE COVER MED ACCU2010

Everything you need for a 510(k) submission. Nothing you don't.