Product code DQD
- Device name
- Stethoscope, Electronic
- Medical specialty
- Cardiovascular
- Device class
- 2
- Regulation number
- 870.1875
- Review panel
- CV
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261494 | Smart Wireless Stethoscope (STEMO310);Smart Wireless Stethoscope (STEMO710);Smart Wireless Stethoscope (STEMO720);Smart Wireless Stethoscope (STEMO730) | Shanghai Hulu Devices Co., Ltd. | 2026-07-31 |
| K261694 | CORE 300 Digital Stethoscope | Eko Health, Inc. | 2026-07-23 |
| K252915 | AiSteth® | Ai Health Highway India Pvt., Ltd. | 2026-05-22 |
| K252089 | Tyto Stethoscope (G3) | Tyto Care , Ltd. | 2026-03-12 |
| K252076 | Kneevoice Cartilage Evaluation System (750-3600-001) | Kneevoice, Inc. | 2026-02-06 |
| K252284 | eMurmur Heart AI | Csd Labs | 2025-12-19 |
| K252595 | Stethophone Pro | Sparrow Acoustics, Inc. | 2025-09-12 |
| K251494 | Eko Foundation Analysis Software with Transformers (EFAST) | Eko Health, Inc. | 2025-08-12 |
| K242971 | AccurSound Electronic Stethoscope (AS101) | Heroic Faith International , Ltd. | 2024-11-25 |
| K240901 | Stethophone | Sparrow Acoustics, Inc. | 2024-09-19 |
| K233313 | Keikku Electronic stethoscope | Lapsi Health Holding B.V. | 2024-04-10 |
| K233609 | CORE 500 Digital Stethoscope | Eko Health, Inc. | 2024-03-28 |
| K231551 | Stethophone | Sparrow Acoustics, Inc. | 2023-10-12 |
| K230613 | SKEEPER | Smartsound Corporation | 2023-08-02 |
| K230823 | AusculThing ACC | Ausculthing OY | 2023-07-12 |
| K230111 | CORE 500 Digital Stethoscope | Eko Devices, Inc. | 2023-05-26 |
| K230769 | PrevisEA Device | Entac Medical, Inc. | 2023-05-19 |
| K223785 | N9+ | Nonagon , Ltd. | 2023-04-14 |
| K222871 | Stethophone v1 | Sparrow Acoustics, Inc. | 2023-03-29 |
| K221805 | AccurSound Electronic Stethoscope AS-101 | Heroic Faith International , Ltd. | 2023-03-23 |
| K212906 | HeartBuds Electronic Stethoscope | Heartbuds, LLC | 2023-03-14 |
| K223166 | Medaica M1 Telehealth Stethoscope | Medaica, Inc. | 2023-01-19 |
| K220466 | ibiomedi Electronic Stethoscope ES-2020 | Sound Land Corp. | 2022-11-03 |
| K220099 | eClinic Stethopod | Homediagnostic, LLC | 2022-10-20 |
| K213794 | Eko Murmur Analysis Software (EMAS) | Eko Devices, Inc. | 2022-06-29 |
| K220766 | eMurmur Heart AI | Csd Labs GmbH | 2022-05-31 |
| K211779 | ES001 Digital stethoscope for general-purpose auscultation, ES002 Digital stethoscope for hearing impaired users, ES003 Digital stethoscope for telemedicine. | Chip Ideas Electronics S.L. | 2022-05-26 |
| K220470 | Smart Wireless Stethoscope | Shanghai Hulu Devices Co., Ltd. | 2022-05-23 |
| K220196 | Steth IO Spot | Stratoscientific | 2022-03-24 |
| K212709 | VoqX Electronic Stethoscope | Sanolla , Ltd. | 2022-03-15 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 06973660370001 | Mintti | Suzhou Melodicare Medical Technology Co., Ltd. | 2026-10-10 |
| 00810209880118 | CORE 500 Digital Stethoscope - Lilac Chestpiece | Eko Health, Inc. | 2026-10-01 |
| 00810209880163 | CORE 500 Digital Stethoscope FIGS Earpiece - Espresso | Eko Health, Inc. | 2026-10-01 |
| 00810209880170 | CORE 500 Digital Stethoscope FIGS Earpiece - Ruby Red | Eko Health, Inc. | 2026-10-01 |
| 00810209880187 | CORE 500 Digital Stethoscope - Ember Chestpiece | Eko Health, Inc. | 2026-10-01 |
| 00810209880217 | CORE 300™ Digital Stethoscope - Black | Eko Health, Inc. | 2026-10-01 |
| 00810209880224 | CORE 300™ Digital Stethoscope - Berry | Eko Health, Inc. | 2026-10-01 |
| 00810209880231 | CORE 300™ Digital Stethoscope - Sunset | Eko Health, Inc. | 2026-10-01 |
| 00810209880248 | CORE 300™ Digital Stethoscope - Pacific | Eko Health, Inc. | 2026-10-01 |
| 00810209880255 | CORE 300™ Digital Stethoscope - Cloud | Eko Health, Inc. | 2026-10-01 |
| 00810209880064 | CORE 500 Digital Stethoscope - Military Green Earpiece | Eko Health, Inc. | 2026-06-12 |
| 00810209880088 | CORE 500 Digital Stethoscope - Military Green Bundle | Eko Health, Inc. | 2026-06-12 |
| 00810209880071 | CORE 500 Digital Stethoscope - Navy Blue Bundle | Eko Health, Inc. | 2026-06-12 |
| 00810209880057 | CORE 500 Digital Stethoscope - Navy Blue Earpiece | Eko Health, Inc. | 2026-06-12 |
| 00810209880026 | CORE 500 Digital Stethoscope FIGS Earpiece - Orange Taffy | Eko Health, Inc. | 2026-04-03 |
| 00810209880019 | CORE 500 Digital Stethoscope FIGS Earpiece - Rapid Response Pink | Eko Health, Inc. | 2026-04-03 |
| 00810209880040 | EFAST (Eko Foundation Analysis Software with Transformers) | Eko Health, Inc. | 2026-01-29 |
| 00810209880002 | CORE 500 Digital Stethoscope FIGS Earpiece - Caribbean Blue | Eko Health, Inc. | 2026-01-29 |
| 00850010298245 | CORE 500 Digital Stethoscope FIGS Earpiece - Black | Eko Health, Inc. | 2025-03-18 |
| 00850010298252 | CORE 500 Digital Stethoscope FIGS Earpiece - Grey | Eko Health, Inc. | 2025-03-18 |
| 00850010298269 | CORE 500 Digital Stethoscope FIGS Earpiece - Mauve | Eko Health, Inc. | 2025-03-18 |
| 00850010298184 | EMAS (Eko Murmur Analysis Software) | Eko Health, Inc. | 2025-03-17 |
| 00850010298160 | Eko CORE 500 Digital Stethoscope Chestpiece | Eko Health, Inc. | 2023-07-10 |
| 00850010298177 | Eko CORE 500 Digital Stethoscope Earpiece | Eko Health, Inc. | 2023-07-10 |
| 00850010298191 | Eko CORE 500 and CAC500 Standard bundle | Eko Health, Inc. | 2023-07-10 |
| 00850010298207 | Eko CORE 500 and CAC500 Founder's Edition bundle | Eko Health, Inc. | 2023-07-10 |
| 00850010298214 | Eko CORE 500 Founder's Edition Chestpiece | Eko Health, Inc. | 2023-07-10 |
| 00850010298030 | Eko Analysis Software | Eko Health, Inc. | 2020-09-08 |
| 00850010298009 | Eko Core Digital Attachment | Eko Health, Inc. | 2019-11-01 |
| 00850010298016 | Eko Core Digital Stethoscope | Eko Health, Inc. | 2019-11-01 |