The following data is part of a premarket notification filed by Koelis with the FDA for Disposable Guides Kdng00.
| Device ID | K180970 |
| 510k Number | K180970 |
| Device Name: | Disposable Guides KDNG00 |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | Koelis 16, Chemin Du Vieux Chene Meylan, FR 38240 |
| Contact | Pauline Nicole |
| Correspondent | Pauline Nicole 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 | 2018-04-13 |
| Decision Date | 2018-07-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03665134000011 | K180970 | 000 |