The following data is part of a premarket notification filed by Boston Scientific Corporation with the FDA for Clearsign Ii Amplifier 40 Channels, Clearsign Ii Amplifier 80 Channels, Clearsign Ii Amplifier 120 Channels, Clearsign Ii Amplifier 160 Channels.
| Device ID | K152693 |
| 510k Number | K152693 |
| Device Name: | CLEARSIGN II Amplifier 40 Channels, CLEARSIGN II Amplifier 80 Channels, CLEARSIGN II Amplifier 120 Channels, CLEARSIGN II Amplifier 160 Channels |
| Classification | Amplifier And Signal Conditioner, Transducer Signal |
| Applicant | BOSTON SCIENTIFIC CORPORATION 55 TECHNOLOGY DR Lowell, MA 01851 |
| Contact | Maylin Truesdell |
| Correspondent | Maylin Truesdell BOSTON SCIENTIFIC CORPORATION 55 TECHNOLOGY DR Lowell, MA 01851 |
| Product Code | DRQ |
| CFR Regulation Number | 870.2060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-21 |
| Decision Date | 2015-10-21 |
| Summary: | summary |