The following data is part of a premarket notification filed by Sms Technologies, Ltd. with the FDA for Sms Balance Performance Monitor.
Device ID | K930089 |
510k Number | K930089 |
Device Name: | SMS BALANCE PERFORMANCE MONITOR |
Classification | Platform, Force-measuring |
Applicant | SMS TECHNOLOGIES, LTD. 45 WEST ST. SUITE 2 ATTLEBORO, MA 02703 |
Contact | TOBY JOHNSTON |
Correspondent | TOBY JOHNSTON SMS TECHNOLOGIES, LTD. 45 WEST ST. SUITE 2 ATTLEBORO, MA 02703 |
Product Code | KHX |
CFR Regulation Number | 890.1575 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-01-08 |
Decision Date | 1993-06-08 |