Name: Predicase
Price: 199 USD

K-number	K192838
Device name	Quantumn Centrifugal Drive- High Pressure, Quantum Centrifugal Drive- Medium Pressure
Applicant	Spectrum Medical , Ltd.
Product code	DWA
Device class	Class II
Decision date	Apr 13, 2020
Decision	Substantially Equivalent
Regulation	870.4380

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 →

Quantumn Centrifugal Drive- High Pressure, Quantum Centrifugal Drive- Medium Pressure

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