Name: Predicase
Price: 199 USD

K-number	K980946
Device name	MARK II CO2 FLUSH MANOMETRIC PERFUSION PUMP & MARK II MANOMETRIC PERFUSION PUMP
Applicant	Dentsleeve Pty., Ltd.
Product code	FFX
Device class	Class II
Decision date	Jun 8, 1998
Decision	Substantially Equivalent
Regulation	876.1725

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 →

MARK II CO2 FLUSH MANOMETRIC PERFUSION PUMP & MARK II MANOMETRIC PERFUSION PUMP

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