The following data is part of a premarket notification filed by Braincare Desenvolvimento E Inovacao Tecnologica S.a. with the FDA for Bcss-picni-2000 Sensor.
| Device ID | K182073 |
| 510k Number | K182073 |
| Device Name: | BcSs-PICNI-2000 Sensor |
| Classification | Device, Monitoring, Intracranial Pressure |
| Applicant | Braincare Desenvolvimento E Inovacao Tecnologica S.A. Rua Cid Silva Cesar, 600 Sala 6, Parque Jardim Santa Felicia Sao Carlos, BR 13562-400 |
| Contact | Arnaldo Betta |
| Correspondent | Connie Qiu M Squared Associates, Inc. 575 8th Ave, Suite 1212 New York, NY 10018 |
| Product Code | GWM |
| CFR Regulation Number | 882.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-08-01 |
| Decision Date | 2019-10-17 |