K211779 - ES001 Digital stethoscope for general-purpose auscultation, ES002 Digital stethoscope for hearing impaired users, ES003 Digital stethoscope for telemedicine. (FDA 510(k) Clearance)

K211779 is an FDA 510(k) clearance for the ES001 Digital stethoscope for general-purpose auscultation, ES002 Digital ste.... Classified as Stethoscope, Electronic (product code DQD), Class II - Special Controls.

Submitted by Chip Ideas Electronics S.L. (Burjasot, ES). The FDA issued a Cleared decision on May 26, 2022 after a review of 351 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1875 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Chip Ideas Electronics S.L. devices