The following data is part of a premarket notification filed by Wrm Computers with the FDA for Cdg Gait Analyses System.
| Device ID | K915278 |
| 510k Number | K915278 |
| Device Name: | CDG GAIT ANALYSES SYSTEM |
| Classification | System, Pressure Measurement, Intermittent |
| Applicant | WRM COMPUTERS P.O. BOX 384 7940 AJ MEPPEL Holland, HN |
| Contact | Wilford Maurits |
| Correspondent | Wilford Maurits WRM COMPUTERS P.O. BOX 384 7940 AJ MEPPEL Holland, HN |
| Product Code | JFC |
| CFR Regulation Number | 890.1600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-11-25 |
| Decision Date | 1992-04-07 |