The following data is part of a premarket notification filed by D. E. Hokanson, Inc. with the FDA for Tl 400 Totalab Vascular Diagnostic System.
| Device ID | K872517 |
| 510k Number | K872517 |
| Device Name: | TL 400 TOTALAB VASCULAR DIAGNOSTIC SYSTEM |
| Classification | Plethysmograph, Photoelectric, Pneumatic Or Hydraulic |
| Applicant | D. E. HOKANSON, INC. 2450 NEWPORT WAY S.E. Issaquah, WA 98027 |
| Contact | Eugene Hokanson |
| Correspondent | Eugene Hokanson D. E. HOKANSON, INC. 2450 NEWPORT WAY S.E. Issaquah, WA 98027 |
| Product Code | JOM |
| CFR Regulation Number | 870.2780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-06-24 |
| Decision Date | 1987-10-01 |