SONOSENTRY
Abnormal Breath Sound Device
ISONEA LTD
The following data is part of a premarket notification filed by Isonea Ltd with the FDA for Sonosentry.
Pre-market Notification Details
| Device ID | K131285 |
| 510k Number | K131285 |
| Device Name: | SONOSENTRY |
| Classification | Abnormal Breath Sound Device |
| Applicant | ISONEA LTD 6965 EL CAMINO REAL SUITE 105-428 Carlsbad, CA 92009 |
| Contact | Korina Akhondzadeh |
| Correspondent | Korina Akhondzadeh ISONEA LTD 6965 EL CAMINO REAL SUITE 105-428 Carlsbad, CA 92009 |
| Product Code | PHZ |
| CFR Regulation Number | 868.1900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-06 |
| Decision Date | 2014-08-19 |
| Summary: | summary |
Trademark Results [SONOSENTRY]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SONOSENTRY 86701005 not registered Dead/Abandoned |
RESPIRI LIMITED 2015-07-22 |
 SONOSENTRY 85555176 not registered Dead/Abandoned |
ISONEA LIMITED 2012-02-28 |
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