The following data is part of a premarket notification filed by D. E. Hokanson, Inc. with the FDA for Model Md-5 Doppler.
| Device ID | K901592 |
| 510k Number | K901592 |
| Device Name: | MODEL MD-5 DOPPLER |
| Classification | Echocardiograph |
| 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 | DXK |
| CFR Regulation Number | 870.2330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-04-05 |
| Decision Date | 1990-10-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817065021464 | K901592 | 000 |
| 00817065021426 | K901592 | 000 |
| 00817065021372 | K901592 | 000 |
| 00817065021365 | K901592 | 000 |
| 00817065021358 | K901592 | 000 |
| 00817065021334 | K901592 | 000 |
| 00817065021327 | K901592 | 000 |
| 00817065021310 | K901592 | 000 |
| 00817065021303 | K901592 | 000 |