Telphonic Stethoscope
FDA 510(k) K945638 · American Telecare, Inc.
510(k) numberK945638
Submission
- Device name
- Telphonic Stethoscope
- Applicant
- American Telecare, Inc.
Eden Prairie, MN, US - Received
- November 16, 1994
- Decision date
- May 17, 1995
- 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 Telphonic Stethoscope cleared by the FDA?
Telphonic Stethoscope (K945638) received a 510(k) decision of Substantially Equivalent on May 17, 1995, 182 days after the submission was received.
What is the product code of K945638?
The FDA product code is DQD – Stethoscope, Electronic, a Class II (moderate risk) device regulated under 21 CFR 870.1875.