The following data is part of a premarket notification filed by D. E. Hokanson, Inc. with the FDA for Non Invasive Vascular Program.
Device ID | K932852 |
510k Number | K932852 |
Device Name: | NON INVASIVE VASCULAR PROGRAM |
Classification | Medical Computers And Software |
Applicant | D. E. HOKANSON, INC. 12840 N.E. 21ST PL. Bellevue, WA 98005 -1910 |
Contact | Eugene Hokanson |
Correspondent | Eugene Hokanson D. E. HOKANSON, INC. 12840 N.E. 21ST PL. Bellevue, WA 98005 -1910 |
Product Code | LNX |
Subsequent Product Code | DSB |
Subsequent Product Code | JOB |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-06-10 |
Decision Date | 1994-02-04 |