The following data is part of a premarket notification filed by Blacktoe Medical Iii, Inc. with the FDA for Soniceye Ultrasound Transducer.
| Device ID | K113832 |
| 510k Number | K113832 |
| Device Name: | SONICEYE ULTRASOUND TRANSDUCER |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | BLACKTOE MEDICAL III, INC. 8305 CREEKSIDE PLACE SUITE C Beaverton, OR 97008 |
| Contact | Kendra Rathkey |
| Correspondent | Kendra Rathkey BLACKTOE MEDICAL III, INC. 8305 CREEKSIDE PLACE SUITE C Beaverton, OR 97008 |
| Product Code | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-12-27 |
| Decision Date | 2012-03-06 |
| Summary: | summary |