SONOSENTRY
FDA 510(k) clearance K131285 · decided 2014-08-19
Clearance details
- K-number
- K131285
- Device name
- SONOSENTRY
- Applicant
- Isonea, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2013-05-06
- Decision date
- 2014-08-19
- Days to decision
- 470 days
- Clearance type
- Traditional
- Product code
- PHZ
- Device class
- 2
- Regulation number
- 868.1900
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Carlsbad, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Isonea
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Tyto Insights for Wheeze Detection (with PCCP) (K252844) | Tyto Care , Ltd. | 2026-06-02 |
| Tyto Insights for Rhonchi Detection (K243567) | Tyto Care , Ltd. | 2025-04-07 |
| Tyto Insights for Crackles Detection (K240555) | Tyto Care , Ltd. | 2024-07-02 |
| Tyto Insights for Wheeze Detection (K232237) | Tyto Care , Ltd. | 2023-12-13 |
| TytoCare Lung Sounds Analyzer (K221614) | Tyto Care , Ltd. | 2023-02-24 |
| wheezo WheezeRate Detector (K202062) | Respiri Limited | 2021-03-11 |
Recalls involving this device
No recalls on record reference this clearance.