Name: Predicase
Price: 199 USD

K-number	K071113
Device name	RT300-S, MODEL FA100052, RT300-SP (PEDIATRIC VERSION), MODEL FA100053
Applicant	Restorative Therapies, Inc.
Product code	GZI
Device class	Class II
Decision date	Jul 5, 2007
Decision	Substantially Equivalent
Regulation	882.5810

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 →

RT300-S, MODEL FA100052, RT300-SP (PEDIATRIC VERSION), MODEL FA100053

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