510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Braincare Desenvolvimento e Inovacao Tecnologica S.A.

Sao Carlos Sao Paulo, BR

BRAINCARE DESENVOLVIMENTO E INOVACAO TECNOLOGICA S.A. appears in FDA device records in Sao Carlos Sao Paulo, BR. FDA records list 3 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
3
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 3 510(k) clearances for Braincare Desenvolvimento e Inovacao Tecnologica S.A. between 2019 and 2024. The busiest year on record is 2019, with 1. The most recent is 2024, with 1.

Clearances by year, as a table
510(k) clearance decisions for Braincare Desenvolvimento e Inovacao Tecnologica S.A., by decision year
YearClearances
20191
20211
20241
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K240821B4C System - Addition of new sensor model (BcSs-PICNIW-2000)GWMSubstantially Equivalent
K201989B4C SystemGWMSubstantially Equivalent
K182073BcSs-PICNI-2000 SensorGWMSubstantially Equivalent

Registered establishments

FDA registered establishments for Braincare Desenvolvimento e Inovacao Tecnologica S.A., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30171808273017180827BRAINCARE DESENVOLVIMENTO E INOVACAO TECNOLOGICA S.A.Av Bruno Ruggiero Filho, 971, Sao Carlos Sao Paulo 13562-420 BR2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain