The following data is part of a premarket notification filed by D. E. Hokanson, Inc. with the FDA for Procord Md3500 Vascular Diagnostic System.
| Device ID | K896034 |
| 510k Number | K896034 |
| Device Name: | PROCORD MD3500 VASCULAR DIAGNOSTIC SYSTEM |
| Classification | Plethysmograph, Impedance |
| 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 | DSB |
| CFR Regulation Number | 870.2770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-10-16 |
| Decision Date | 1990-01-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817065022492 | K896034 | 000 |
| 00817065022515 | K896034 | 000 |
| 00817065021389 | K896034 | 000 |
| 00817065021433 | K896034 | 000 |
| 00817065021457 | K896034 | 000 |
| 00817065021471 | K896034 | 000 |
| 00817065021488 | K896034 | 000 |
| 00817065022416 | K896034 | 000 |
| 00817065022447 | K896034 | 000 |
| 00817065022461 | K896034 | 000 |
| 00817065022577 | K896034 | 000 |