Adscope 657BK Electronic Stethoscope, Model 657BK
FDA 510(k) K060321 · American Diagnostic Corp.
510(k) numberK060321
Submission
- Device name
- Adscope 657BK Electronic Stethoscope, Model 657BK
- Applicant
- American Diagnostic Corp.
Hauppauge, NY, US - Received
- February 9, 2006
- Decision date
- May 15, 2006
- 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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Questions and answers
When was Adscope 657BK Electronic Stethoscope, Model 657BK cleared by the FDA?
Adscope 657BK Electronic Stethoscope, Model 657BK (K060321) received a 510(k) decision of Substantially Equivalent on May 15, 2006, 95 days after the submission was received.
What is the product code of K060321?
The FDA product code is DQD – Stethoscope, Electronic, a Class II (moderate risk) device regulated under 21 CFR 870.1875.