510(k) K201077
- Device
- Strados Remote Electronic Stethoscope Platform (RESP)
- Applicant
- Strados Labs
- 510(k) number
- K201077
- Product code
- DQD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2020-12-20
- Date received
- 2020-04-22
- Regulation
- 870.1875
- Classification name
- Stethoscope, Electronic
- Medical specialty
- Cardiovascular
- Review panel
- Anesthesiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Nicholas Delmonico
- Address
- 1315 Walnut St., Suite 1101 Philadelphia PA US 19107 19107
FDA Registration Numbers#
- 3010381606
- 2017865
- 3003971136
- 8030978
- 3014226707
- 3009077524
- 2132111
- 3003584029
- 3007663004
- 3007208829
- 3006258337
- 9680510
- 3016701404
- 1316463
- 3012032144
- 3013500228
- 3042167640
- 3014848734
- 1218950
- 3012528160
- 3000126629
- 3014235520
- 3016618143
- 3021332567
- 9610816
- 3030721635
- 3014111150
- 3014522540
- 3029915537
- 3007184699
- 3021769057
- 3009499478
- 3010082909
- 3004009431
- 3010576710
- 3024821700
- 3013596024
- 3013889955
- 1527715
- 3010342616
- 3006087789
- 3003263092
- 3008773647
- 3006733253
- 2133409
- 3004035727
- 3002808458
- 3030310221
- 3024673
- 3014929383
- 3005737664
- 3008505660
- 3014271754
- 3043479346
- 3016812424
- 3026042935
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 |
| 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 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases