Name: Predicase
Price: 199 USD

K-number	K211779
Device name	ES001 Digital stethoscope for general-purpose auscultation, ES002 Digital stethoscope for hearing impaired users, ES003 Digital stethoscope for telemedicine.
Applicant	Chip Ideas Electronics S.L.
Product code	DQD
Device class	Class II
Decision date	May 26, 2022
Decision	Substantially Equivalent
Regulation	870.1875

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 →

ES001 Digital stethoscope for general-purpose auscultation, ES002 Digital stethoscope for hearing impaired users, ES003 Digital stethoscope for telemedicine.

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