Caretone II
FDA 510(k) K963678 · American Telecare, Inc.
510(k) numberK963678
Submission
- Device name
- Caretone II
- Applicant
- American Telecare, Inc.
Washington, DC, US - Received
- September 13, 1996
- Decision date
- February 24, 1997
- 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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| 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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| K993550 | Aviva System, Model SL1010DRG · Traditional | 01/13/2000SE |
| K981533 | Aviva Systems Model Numbers 1010, 2020DRG · Traditional | 07/15/1998SE |
| K973873 | Digital Personal Telemedicine Module, Digital PTM 1DRG · Traditional | 12/29/1997SE |
| K964554 | Personal Telemedicine ModuleDRG · Traditional | 12/17/1996SE |
| K952882 | Personal Telemedicine SystemDXN · Traditional | 09/09/1996SE |
| K945638 | Telphonic StethoscopeDQD · Traditional | 05/17/1995SE |
Questions and answers
When was Caretone II cleared by the FDA?
Caretone II (K963678) received a 510(k) decision of Substantially Equivalent on February 24, 1997, 164 days after the submission was received.
What is the product code of K963678?
The FDA product code is DQD – Stethoscope, Electronic, a Class II (moderate risk) device regulated under 21 CFR 870.1875.