510(k) K252089
- Device
- Tyto Stethoscope (G3)
- Applicant
- Tyto Care , Ltd.
- 510(k) number
- K252089
- Product code
- DQD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-03-12
- Date received
- 2025-07-02
- Regulation
- 870.1875
- Classification name
- Stethoscope, Electronic
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Stella Raizelman Perry
- Address
- 14 Beni Gaon St. Netanya IL
FDA Registration Numbers#
- 1000548922
- 1926681
- 3042167640
- 8010482
- 3015907115
- 3008820594
- 3016678045
- 3016864576
- 3004215265
- 3016442138
- 3010262192
- 3018783553
- 3017829091
- 3010106598
- 3004009431
- 3038129050
- 3031841433
- 3001149827
- 3015134086
- 3002736372
- 3030310221
- 3013689228
- 3009756153
- 3036497156
- 3007615597
- 3018117676
- 3012678246
- 3003174284
- 3011359729
- 3010399798
- 3042272797
- 3024491912
- 3000130829
- 3012494290
- 3004582233
- 3012421607
- 3030626857
- 2434008
- 3013557562
- 3009715978
- 3008293988
- 3013757696
- 3043226252
- 3011651230
- 3017394506
- 3017026146
- 3010097171
Source Documents#
Other 510(k) Records For Product Code DQD#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252915 | AiSteth® | Ai Health Highway India Pvt., Ltd. | 2026-05-22 |
| 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 |