The following data is part of a premarket notification filed by Chip Ideas Electronics S.l. with the FDA for Es001 Digital Stethoscope For General-purpose Auscultation, Es002 Digital Stethoscope For Hearing Impaired Users, Es003 Digital Stethoscope For Telemedicine..
Device ID | K211779 |
510k Number | K211779 |
Device Name: | ES001 Digital Stethoscope For General-purpose Auscultation, ES002 Digital Stethoscope For Hearing Impaired Users, ES003 Digital Stethoscope For Telemedicine. |
Classification | Stethoscope, Electronic |
Applicant | Chip Ideas Electronics S.L. Calle Alfareria 3 B Burjasot, ES 46100 |
Contact | Bernardo Plaza Trillo |
Correspondent | Bernardo Plaza Trillo Chip Ideas Electronics S.L. Calle Alfareria 3 B Burjasot, ES 46100 |
Product Code | DQD |
CFR Regulation Number | 870.1875 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-06-09 |
Decision Date | 2022-05-26 |