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 |