Name: Predicase
Price: 199 USD

K-number	K953417
Device name	MINIFLEX MODEL 340, 341, AND 342 PULSE GENERATORS
Applicant	Cook Pacemaker Corp.
Product code	DXY
Device class	Class III
Decision date	Sep 29, 1995
Decision	Substantially Equivalent - Subject to Tracking Reg.
Regulation	870.3610

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 →

MINIFLEX MODEL 340, 341, AND 342 PULSE GENERATORS

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