The following data is part of a premarket notification filed by Braincare Desenvolvimento E Inovacao Tecnologica S.a. with the FDA for B4c System.
| Device ID | K201989 |
| 510k Number | K201989 |
| Device Name: | B4C System |
| Classification | Device, Monitoring, Intracranial Pressure |
| Applicant | Braincare Desenvolvimento E Inovacao Tecnologica S.A. Avenida Bruno Ruggiero Filho, 971 Sao Carlos, BR 13562-420 |
| Contact | Arnaldo Betta |
| Correspondent | Connie Qiu M Squared Associates,Inc. 127 West 30th Street, 9th Floor New York, NY 10001 |
| Product Code | GWM |
| CFR Regulation Number | 882.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-07-17 |
| Decision Date | 2021-10-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07908398200237 | K201989 | 000 |
| 07908398200251 | K201989 | 000 |
| 07908398200060 | K201989 | 000 |
| 07908398200077 | K201989 | 000 |
| 07908398200084 | K201989 | 000 |
| 07908398200091 | K201989 | 000 |
| 07908398200107 | K201989 | 000 |
| 07908398200114 | K201989 | 000 |
| 07908398200121 | K201989 | 000 |
| 07908398200138 | K201989 | 000 |
| 07908398200145 | K201989 | 000 |
| 07908398200152 | K201989 | 000 |
| 07908398200169 | K201989 | 000 |
| 07908398200176 | K201989 | 000 |
| 07908398200183 | K201989 | 000 |
| 07908398200190 | K201989 | 000 |
| 07908398200206 | K201989 | 000 |
| 07908398200220 | K201989 | 000 |
| 07908398200244 | K201989 | 000 |