Dif-Stet
FDA 510(k) K832882 · Intersect Systems, Inc.
510(k) numberK832882
Submission
- Device name
- Dif-Stet
- Applicant
- Intersect Systems, Inc.
Mchenry, IL, US - Received
- August 26, 1983
- Decision date
- December 6, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DQD – Stethoscope, Electronic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1875
- Specialty
- Cardiovascular
Other 510(k)s with product code DQD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261494 | Smart Wireless Stethoscope (STEMO310);Smart Wireless Stethoscope (STEMO710);Smart…DQD · Traditional | Shanghai Hulu Devices Co., Ltd. | 07/31/2026SE |
| 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 |
| K252089 | Tyto Stethoscope (G3)DQD · Traditional | Tyto Care , Ltd. | 03/12/2026SE |
| 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 |
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| 510(k) | Device | Decision |
|---|---|---|
| K021636 | Albumin ReagentCJW · Traditional | 07/17/2002SE |
| K011972 | Direct Bilirubin ReagentCIG · Traditional | 08/27/2001SE |
| K011692 | Homogeneous Enzymic Homocysteine ReagentLPS · Traditional | 07/25/2001SE |
| K003892 | Total Bilirubin ReagentCIG · Traditional | 02/20/2001SE |
| K983937 | Dual Vial Creatinine ReagentCGX · Traditional | 01/06/1999SE |
| K974833 | Ck-Nac ReagentCGS · Traditional | 02/13/1998SE |
| K941807 | Intersect Systems' Non-Mercuric Chloride ReagentCHG · Traditional | 09/14/1994SE |
| K932888 | Intersect Systems Direct Amylase ReagentJFJ · Traditional | 01/31/1994SE |
| K934039 | Intersect Systems HDL Cholesterol Reagent SetLBR · Traditional | 11/16/1993SE |
| K932267 | Enzymatic CO2 Reagent, ModificationKHS · Traditional | 09/24/1993SE |
Questions and answers
When was Dif-Stet cleared by the FDA?
Dif-Stet (K832882) received a 510(k) decision of Substantially Equivalent on December 6, 1983, 102 days after the submission was received.
What is the product code of K832882?
The FDA product code is DQD – Stethoscope, Electronic, a Class II (moderate risk) device regulated under 21 CFR 870.1875.