Zargis Acoustic Cardioscan
FDA 510(k) K031517 · Zargis Medical Corp.
510(k) numberK031517
Submission
- Device name
- Zargis Acoustic Cardioscan
- Applicant
- Zargis Medical Corp.
Princeton, NJ, US - Received
- May 15, 2003
- Decision date
- May 26, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DQD – Stethoscope, Electronic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1875
- Specialty
- Cardiovascular
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| K261694 | CORE 300 Digital StethoscopeDQD · Traditional | Eko Health, Inc. | 07/23/2026SE |
| K252915 | AiSteth®DQD · Traditional | Ai Health Highway India Pvt., Ltd. | 05/22/2026SE |
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| K252076 | Kneevoice Cartilage Evaluation System (750-3600-001)DQD · Traditional | Kneevoice, Inc. | 02/06/2026SE |
| K252284 | eMurmur Heart AIDQD · Traditional | Csd Labs | 12/19/2025SE |
| K252595 | Stethophone ProDQD · Special | Sparrow Acoustics, Inc. | 09/12/2025SE |
| K251494 | Eko Foundation Analysis Software with Transformers (EFAST)DQD · Traditional | Eko Health, Inc. | 08/12/2025SE |
| K242971 | AccurSound Electronic Stethoscope (AS101)DQD · Traditional | Heroic Faith International , Ltd. | 11/25/2024SE |
| K240901 | StethophoneDQD · Traditional | Sparrow Acoustics, Inc. | 09/19/2024SE |
More from Sparrow Acoustics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K090493 | SignalDQD · Traditional | 08/07/2009SE |
| K083309 | Zargis Acoustic Cardioscan, Version 9.33DQD · Special | 02/13/2009SE |
| K060197 | Zargis Acoustic Cardioscan (Zac), Model Zac 6.28DQD · Special | 03/29/2006SE |
| K042128 | Modification to Zargis Acoustic Cardioscan (Zac)DQD · Special | 09/08/2004SE |
Questions and answers
When was Zargis Acoustic Cardioscan cleared by the FDA?
Zargis Acoustic Cardioscan (K031517) received a 510(k) decision of Substantially Equivalent on May 26, 2004, 377 days after the submission was received.
What is the product code of K031517?
The FDA product code is DQD – Stethoscope, Electronic, a Class II (moderate risk) device regulated under 21 CFR 870.1875.