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 |
|---|---|---|---|
| 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 |
| K212013 | eKuore Pro 4T - REF EP0098 | Chip Ideas Electronics S.L. | 2021-11-10 |
| K211068 | PrevisEA Device | Entac Medical, Inc. | 2021-08-04 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08883000007413 | AeviceMD | AEVICE HEALTH PTE. LTD. | 2026-05-18 |
| 08809427311032 | Skeeper | Smartsound Corportation | 2026-01-12 |
| 20860006382302 | SENSINEL™ CPM REPLACEMENT ADHESIVES (15 Pack) | Analog Devices, Inc. | 2025-03-13 |
| 09353278000823 | Kosmos OTS iOS | ECHONOUS, INC. | 2025-02-21 |
| 09353278000854 | Kosmos Link | ECHONOUS, INC. | 2025-02-21 |
| 27290018446151 | Nonagon N9+ SmartExam | NONAGON LTD | 2022-09-28 |
| 09353278000441 | Kosmos Torso - Refurbished | ECHONOUS, INC. | 2020-12-11 |
| 09353278000458 | Kosmos Bridge - Refurbished | ECHONOUS, INC. | 2020-12-11 |
| 09353278000120 | Kosmos Bridge | ECHONOUS, INC. | 2020-05-06 |
| 09353278000137 | Kosmos Torso | ECHONOUS, INC. | 2020-05-06 |
| 00634782055455 | Adscope® | AMERICAN DIAGNOSTIC CORP | 2018-04-27 |
| 00634782086893 | Adscope® | AMERICAN DIAGNOSTIC CORP | 2017-05-27 |
| 00634782086886 | Adscope® | AMERICAN DIAGNOSTIC CORP | 2017-05-27 |
| 00634782083328 | Adscope® | AMERICAN DIAGNOSTIC CORP | 2017-03-31 |
| 00634782083359 | Adscope® | AMERICAN DIAGNOSTIC CORP | 2017-03-31 |
| 00634782083342 | Adscope® | AMERICAN DIAGNOSTIC CORP | 2017-03-31 |
| 00634782083335 | Adscope® | AMERICAN DIAGNOSTIC CORP | 2017-03-31 |
| 00634782083311 | Adscope® | AMERICAN DIAGNOSTIC CORP | 2017-03-31 |
| 00634782083304 | Adscope® | AMERICAN DIAGNOSTIC CORP | 2017-03-31 |
| 00634782083298 | Adscope® | AMERICAN DIAGNOSTIC CORP | 2017-03-31 |
| 00634782054793 | Adscope® | AMERICAN DIAGNOSTIC CORP | 2017-03-31 |
| 00707387765422 | Littmann® | 3M COMPANY | 2016-09-24 |
| 00707387765439 | Littmann® | 3M COMPANY | 2016-09-24 |
| 00707387765446 | Littmann® | 3M COMPANY | 2016-09-24 |
| 00707387765453 | Littmann® | 3M COMPANY | 2016-09-24 |
| 00707387765460 | Littmann® | 3M COMPANY | 2016-09-24 |
| 00707387765477 | Littmann® | 3M COMPANY | 2016-09-24 |
| 00707387765507 | Littmann® | 3M COMPANY | 2016-09-24 |
| 00707387765514 | Littmann® | 3M COMPANY | 2016-09-24 |
| 00707387765521 | Littmann® | 3M COMPANY | 2016-09-24 |