The following data is part of a premarket notification filed by Interlogics, Inc. with the FDA for Interlogics W-tracker And Wrist Works Software.
Device ID | K971079 |
510k Number | K971079 |
Device Name: | INTERLOGICS W-TRACKER AND WRIST WORKS SOFTWARE |
Classification | Goniometer, Ac-powered |
Applicant | INTERLOGICS, INC. P.O. BOX 1239 Hillsborough, NC 27278 |
Contact | Donald R Mcintyre |
Correspondent | Donald R Mcintyre INTERLOGICS, INC. P.O. BOX 1239 Hillsborough, NC 27278 |
Product Code | KQX |
CFR Regulation Number | 888.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-03-25 |
Decision Date | 1997-07-09 |