Name: Predicase
Price: 199 USD

K-number	K101589
Device name	BLANKETROL III, MODEL 233 AND COOLBLUE, MODEL 25-01 HYPER-HYPOTHERMIA SYSTEMS
Applicant	Cincinnati Sub-Zero Products, Inc.
Product code	DWJ
Device class	Class II
Decision date	Sep 20, 2010
Decision	Substantially Equivalent
Regulation	870.5900

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 →

BLANKETROL III, MODEL 233 AND COOLBLUE, MODEL 25-01 HYPER-HYPOTHERMIA SYSTEMS

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