The following data is part of a premarket notification filed by Medicaa (uruguay) S.a. with the FDA for Balance Rehabilitation Unit (bru).
| Device ID | K070085 |
| 510k Number | K070085 |
| Device Name: | BALANCE REHABILITATION UNIT (BRU) |
| Classification | Apparatus, Vestibular Analysis |
| Applicant | MEDICAA (URUGUAY) S.A. 1101 SOUTH CAPITAL TEXAS HWY. SUITE F254 Austin, TX 78746 |
| Contact | Ian Gordon |
| Correspondent | Ian Gordon MEDICAA (URUGUAY) S.A. 1101 SOUTH CAPITAL TEXAS HWY. SUITE F254 Austin, TX 78746 |
| Product Code | LXV |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-01-09 |
| Decision Date | 2007-02-26 |
| Summary: | summary |