The following data is part of a premarket notification filed by Koelis with the FDA for Reusable Guide.
| Device ID | K141334 |
| 510k Number | K141334 |
| Device Name: | REUSABLE GUIDE |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | KOELIS 5 Avenue Du Grand Sablon La Tronche, FR 38700 |
| Contact | Laetitia Gervais |
| Correspondent | Laetitia Gervais KOELIS 5 Avenue Du Grand Sablon La Tronche, FR 38700 |
| Product Code | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-05-21 |
| Decision Date | 2014-07-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03665134000059 | K141334 | 000 |