510(k) K150235 ยท DRQ Amplifier And Signal Conditioner, Transducer Signal
CLEARSIGN II Amplifier, 40 channels, CLEARSIGN II Amplifier, 80 channels, CLEARSIGN II Amplifier, 120 channels, CLEARSIGN II Amplifer, 160 channels
| Applicant | Boston Scientific Corporation, Lowell MA, US |
| Decision | Substantially Equivalent, Apr 22, 2015 |
| Received | Feb 2, 2015 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K150235
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 18, 2015 | Boston Scientific Corporation CLEARSIGN II Amplifier for LABSYSTEM PRO EP Recording System, 120 channels, using firmware version 2.08. The channel numbers in the amplifier are as follows:
Material number: H30120020210 - 40 Channe Terminated |
DRQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.