Adscope 658 Electronic Stethoscope
FDA 510(k) K162589 · American Diagnostic Corp.
510(k) numberK162589
Submission
- Device name
- Adscope 658 Electronic Stethoscope
- Applicant
- American Diagnostic Corp.
Hauppauge, NY, US - Received
- September 16, 2016
- Decision date
- March 10, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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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| K932145 | Coagulation Reference Plasma, NormalGIZ · Traditional | 10/18/1993SE |
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Questions and answers
When was Adscope 658 Electronic Stethoscope cleared by the FDA?
Adscope 658 Electronic Stethoscope (K162589) received a 510(k) decision of Substantially Equivalent on March 10, 2017, 175 days after the submission was received.
What is the product code of K162589?
The FDA product code is DQD – Stethoscope, Electronic, a Class II (moderate risk) device regulated under 21 CFR 870.1875.