The following data is part of a premarket notification filed by Opsens, Inc. with the FDA for Opto Wire And Optomonitor System.
| Device ID | K142598 |
| 510k Number | K142598 |
| Device Name: | Opto Wire And OptoMonitor System |
| Classification | Wire, Guide, Catheter |
| Applicant | Opsens, Inc. 2014 Rue Cyrille Duquet, #125 Quebec, CA G1n 4n6 |
| Contact | Vanessa Mootoosamy |
| Correspondent | Pamela Papineau DELPHI MEDICAL DEVICE CONSULTING, INC. 5 WHITCOMB AVE Ayer, MA 01432 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-15 |
| Decision Date | 2015-06-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07540184020300 | K142598 | 000 |
| 07540184011117 | K142598 | 000 |
| 07540184011100 | K142598 | 000 |
| 07540184011094 | K142598 | 000 |
| 07540184011087 | K142598 | 000 |
| 07540184011070 | K142598 | 000 |
| 07540184011063 | K142598 | 000 |
| 07540184011056 | K142598 | 000 |
| 07540184011049 | K142598 | 000 |
| 07540184011032 | K142598 | 000 |
| 07540184011025 | K142598 | 000 |
| 07540184011018 | K142598 | 000 |
| 07540184010042 | K142598 | 000 |
| 07540184011124 | K142598 | 000 |
| 07540184012015 | K142598 | 000 |
| 07540184020201 | K142598 | 000 |
| 07540184020102 | K142598 | 000 |
| 07540184020010 | K142598 | 000 |
| 07540184012138 | K142598 | 000 |
| 07540184012121 | K142598 | 000 |
| 07540184012114 | K142598 | 000 |
| 07540184012107 | K142598 | 000 |
| 07540184012091 | K142598 | 000 |
| 07540184012053 | K142598 | 000 |
| 07540184012046 | K142598 | 000 |
| 07540184012039 | K142598 | 000 |
| 07540184012022 | K142598 | 000 |
| 07540184010035 | K142598 | 000 |