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 |