Name: Predicase
Price: 199 USD

K-number	K881478
Device name	MODIFIED KEYMED FLEXIBLE ESOPHAGEAL DILATORS
Applicant	Keymed (Medical & Industrial Equipment), Ltd.
Product code	KNQ
Device class	Class II
Decision date	Sep 14, 1988
Decision	Substantially Equivalent
Regulation	876.5365

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 →

MODIFIED KEYMED FLEXIBLE ESOPHAGEAL DILATORS

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