Name: Predicase
Price: 199 USD

K-number	K061942
Device name	TYMPANIC TEMPERATURE PROBE WITH FOAM, MODEL M1024233; WITHOUT FOAM MODEL M1024237
Applicant	GE Healthcare
Product code	FLL
Device class	Class II
Decision date	Sep 29, 2006
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 →

TYMPANIC TEMPERATURE PROBE WITH FOAM, MODEL M1024233; WITHOUT FOAM MODEL M1024237

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