The following data is part of a premarket notification filed by Condor Instruments Ltda. - Epp with the FDA for Acttrust.
| Device ID | K151784 |
| 510k Number | K151784 |
| Device Name: | ActTrust |
| Classification | Device, Sleep Assessment |
| Applicant | CONDOR INSTRUMENTS LTDA. - EPP AVENIDA BRIGADEIRO LUIS ANTONIO, 551, CJ 124 Sao Paulo, BR 01318-000 |
| Contact | Rodrigo Trevisan Okamoto |
| Correspondent | Rodrigo Trevisan Okamoto CONDOR INSTRUMENTS LTDA. - EPP AVENIDA BRIGADEIRO LUIS ANTONIO, 551, CJ 124 Sao Paulo, BR 01318-000 |
| Product Code | LEL |
| CFR Regulation Number | 882.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-07-01 |
| Decision Date | 2016-05-25 |
| Summary: | summary |