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 |