The following data is part of a premarket notification filed by Opsens Inc. with the FDA for Optowire Iii.
| Device ID | K191907 |
| 510k Number | K191907 |
| Device Name: | OptoWire III |
| Classification | Wire, Guide, Catheter |
| Applicant | Opsens Inc. 750 Boulevard Du Parc Technologique Québec, CA G1p 4s3 |
| Contact | Marc Chaunet |
| Correspondent | Chris Henza Ultra LifeScience Solutions Inc. 872 S. Milwaukee Ave #286 Libertyville, IL 60048 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-07-16 |
| Decision Date | 2020-01-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07540184010325 | K191907 | 000 |