Name: Predicase
Price: 199 USD

K-number	K092256
Device name	THERA- HEAT HEATED HUMIDIFIER, MODEL RC70000, RC70072, RC70075, RC70077, RC70012
Applicant	Smiths Medical Asd, Inc.
Product code	BTT
Device class	Class II
Decision date	Oct 20, 2010
Decision	Substantially Equivalent
Regulation	868.5450

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 →

THERA- HEAT HEATED HUMIDIFIER, MODEL RC70000, RC70072, RC70075, RC70077, RC70012

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