The following data is part of a premarket notification filed by Quantitative with the FDA for Trauma Care Evaluation.
Device ID | K843905 |
510k Number | K843905 |
Device Name: | TRAUMA CARE EVALUATION |
Classification | Medical Computers And Software |
Applicant | QUANTITATIVE 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | LNX |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-10-03 |
Decision Date | 1985-09-26 |