The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Borealis Amplifier (clearsign), Model 2001232 160 Channel Version, 2001267 80 Channel Version, 2001268 40 Channel Versio.
| Device ID | K050006 |
| 510k Number | K050006 |
| Device Name: | BOREALIS AMPLIFIER (CLEARSIGN), MODEL 2001232 160 CHANNEL VERSION, 2001267 80 CHANNEL VERSION, 2001268 40 CHANNEL VERSIO |
| Classification | Amplifier And Signal Conditioner, Transducer Signal |
| Applicant | C.R. BARD, INC. 55 TECHNOLOGY DR. Lowell, MA 01851 |
| Contact | Deborah L Herrington |
| Correspondent | Deborah L Herrington C.R. BARD, INC. 55 TECHNOLOGY DR. Lowell, MA 01851 |
| Product Code | DRQ |
| CFR Regulation Number | 870.2060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-01-03 |
| Decision Date | 2005-05-27 |
| Summary: | summary |