The following data is part of a premarket notification filed by Sms Technologies, Ltd. with the FDA for Community Balance Performance Monitor Or Community Bpm.
| Device ID | K951771 |
| 510k Number | K951771 |
| Device Name: | COMMUNITY BALANCE PERFORMANCE MONITOR OR COMMUNITY BPM |
| Classification | Platform, Force-measuring |
| Applicant | SMS TECHNOLOGIES, LTD. ELIZABETH HOUSE ELIZABETH WAY HARLOW, ESSEX, GB CM19 5TL |
| Contact | ALAN WENMAN |
| Correspondent | ALAN WENMAN SMS TECHNOLOGIES, LTD. ELIZABETH HOUSE ELIZABETH WAY HARLOW, ESSEX, GB CM19 5TL |
| Product Code | KHX |
| CFR Regulation Number | 890.1575 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-04-17 |
| Decision Date | 1995-08-11 |