The following data is part of a premarket notification filed by Penny And Giles Biometrics Ltd. with the FDA for Boost, Mice, Gamesys..
| Device ID | K924416 |
| 510k Number | K924416 |
| Device Name: | BOOST, MICE, GAMESYS. |
| Classification | Goniometer, Ac-powered |
| Applicant | PENNY AND GILES BIOMETRICS LTD. BLACKWOOD GWENT NP22YD UNITED KINGDOM England, GB |
| Contact | Ian Thomas |
| Correspondent | Ian Thomas PENNY AND GILES BIOMETRICS LTD. BLACKWOOD GWENT NP22YD UNITED KINGDOM England, GB |
| Product Code | KQX |
| CFR Regulation Number | 888.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-08-31 |
| Decision Date | 1993-06-15 |