The following data is part of a premarket notification filed by Transonic Systems, Inc. with the FDA for Transonic Elsa System.
| Device ID | K134051 |
| 510k Number | K134051 |
| Device Name: | TRANSONIC ELSA SYSTEM |
| Classification | Computer, Diagnostic, Pre-programmed, Single-function |
| Applicant | TRANSONIC SYSTEMS, INC. 34 Dutch Mill Rd Ithaca, NY 14850 |
| Contact | Naveen Thuramalla |
| Correspondent | Naveen Thuramalla TRANSONIC SYSTEMS, INC. 34 Dutch Mill Rd Ithaca, NY 14850 |
| Product Code | DXG |
| CFR Regulation Number | 870.1435 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-12-31 |
| Decision Date | 2015-01-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00877466000406 | K134051 | 000 |
| 00877466000390 | K134051 | 000 |
| 00877466000383 | K134051 | 000 |
| 00877466000376 | K134051 | 000 |
| 08774660000404 | K134051 | 000 |
| 08774660000398 | K134051 | 000 |
| 08774660000381 | K134051 | 000 |
| 08774660000374 | K134051 | 000 |