FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
TytoCare Lung Sounds Analyzer
K Number: K221614
·
Decision Feb 24, 2023
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
6
Applicant Total
10
Review Days
266
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Basic Information
- Device Name
- TytoCare Lung Sounds Analyzer
- K Number
- K221614
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1900
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Tyto Care , Ltd.
- Date Received
- June 3, 2022
- Decision Date
- February 24, 2023
- Product Code
- PHZ
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| PHZ | Abnormal Breath Sound Device | FDA class 2 | Anesthesiology |
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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 |
| K190242 | Tyto Thermometer | Mar 27, 2019 | Substantially Equivalent |
| K181612 | Tyto Stethoscope (OTC) | Dec 17, 2018 | Substantially Equivalent |
| K160401 | Tyto Stethoscope | Oct 19, 2016 | Substantially Equivalent |