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 Amplifer, 160 Channels.
| Device ID | K150235 |
| 510k Number | K150235 |
| Device Name: | CLEARSIGN II Amplifier, 40 Channels, CLEARSIGN II Amplifier, 80 Channels, CLEARSIGN II Amplifier, 120 Channels, CLEARSIGN II Amplifer, 160 Channels |
| Classification | Amplifier And Signal Conditioner, Transducer Signal |
| Applicant | BOSTON SCIENTIFIC CORPORATION 55 TECHNOLOGY DRIVE Lowell, MA 01851 |
| Contact | Maylin Truesdell |
| Correspondent | Maylin Truesdell BOSTON SCIENTIFIC CORPORATION 55 TECHNOLOGY DRIVE 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 | 2015-02-02 |
| Decision Date | 2015-04-22 |
| Summary: | summary |