FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
Tyto Stethoscope (OTC)
K Number: K181612
·
Decision Dec 17, 2018
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
153
Applicant Total
10
Review Days
181
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Basic Information
- Device Name
- Tyto Stethoscope (OTC)
- K Number
- K181612
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1875
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Tyto Care , Ltd.
- Date Received
- June 19, 2018
- Decision Date
- December 17, 2018
- Product Code
- DQD
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DQD | Stethoscope, Electronic | FDA class 2 | Cardiovascular |
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Other Clearances by Tyto Care , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K252844 | Tyto Insights for Wheeze Detection (with PCCP) | Jun 2, 2026 | Substantially Equivalent |
| DEN250014 | Tyto Insights for Eardrum Bulging Detection | Mar 17, 2026 | Unknown |
| K252089 | Tyto Stethoscope (G3) | Mar 12, 2026 | Substantially Equivalent |
| K243567 | Tyto Insights for Rhonchi Detection | Apr 7, 2025 | Substantially Equivalent |
| K240555 | Tyto Insights for Crackles Detection | Jul 2, 2024 | Substantially Equivalent |
| K232237 | Tyto Insights for Wheeze Detection | Dec 13, 2023 | Substantially Equivalent |
| K221614 | TytoCare Lung Sounds Analyzer | Feb 24, 2023 | Substantially Equivalent |
| K190242 | Tyto Thermometer | Mar 27, 2019 | Substantially Equivalent |
| K160401 | Tyto Stethoscope | Oct 19, 2016 | Substantially Equivalent |