The following data is part of a premarket notification filed by Applied Biomedical Computations, Inc. with the FDA for Computer Assisted Diabetic Intruction.
| Device ID | K854249 |
| 510k Number | K854249 |
| Device Name: | COMPUTER ASSISTED DIABETIC INTRUCTION |
| Classification | Medical Computers And Software |
| Applicant | APPLIED BIOMEDICAL COMPUTATIONS, INC. 815 CONNECTICUT AVE. Washington, DC 20006 |
| Contact | Jonathan S Kahan |
| Correspondent | Jonathan S Kahan APPLIED BIOMEDICAL COMPUTATIONS, INC. 815 CONNECTICUT AVE. Washington, DC 20006 |
| 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 | 1985-10-22 |
| Decision Date | 1986-03-27 |