The following data is part of a premarket notification filed by Koelis with the FDA for Reusable Guides Ranges (perine Range, Nail Range, Con-lead Range And Lin-lead Range) And Steady Pro Range.
| Device ID | K171040 |
| 510k Number | K171040 |
| Device Name: | Reusable Guides Ranges (PERINE Range, NAIL Range, CON-LEAD Range And LIN-LEAD Range) And STEADY PRO Range |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | Koelis 16, Chemin Du Vieux Chene Meylan, FR 38240 |
| Contact | Laetitia Gervais |
| Correspondent | Laetitia Gervais Koelis 16, Chemin Du Vieux Chene Meylan, FR 38240 |
| Product Code | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-04-06 |
| Decision Date | 2017-07-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03665134000202 | K171040 | 000 |
| 03665134000189 | K171040 | 000 |
| 03665134000301 | K171040 | 000 |
| 03665134000318 | K171040 | 000 |
| 03665134000158 | K171040 | 000 |
| 03665134000325 | K171040 | 000 |
| 03665134000738 | K171040 | 000 |
| 03665134000745 | K171040 | 000 |
| 03665134000783 | K171040 | 000 |
| 03665134000806 | K171040 | 000 |
| 03665134000110 | K171040 | 000 |
| 03665134000172 | K171040 | 000 |
| 03665134000141 | K171040 | 000 |
| 03665134000134 | K171040 | 000 |
| 03665134000936 | K171040 | 000 |