The following data is part of a premarket notification filed by D. E. Hokanson, Inc. with the FDA for Nivp3 (windows Version Of Nivp.
| Device ID | K970570 |
| 510k Number | K970570 |
| Device Name: | NIVP3 (WINDOWS VERSION OF NIVP |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | D. E. HOKANSON, INC. 12840 N.E. 21ST PL. Bellevue, WA 98005 -1910 |
| Contact | D. E Hokanson |
| Correspondent | D. E Hokanson D. E. HOKANSON, INC. 12840 N.E. 21ST PL. Bellevue, WA 98005 -1910 |
| Product Code | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-02-14 |
| Decision Date | 1997-10-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817065021532 | K970570 | 000 |
| 00817065021525 | K970570 | 000 |
| 00817065021518 | K970570 | 000 |
| 00817065021174 | K970570 | 000 |
| 00817065021167 | K970570 | 000 |
| 00817065021150 | K970570 | 000 |
| 00817065021143 | K970570 | 000 |
| 00817065021136 | K970570 | 000 |