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 |