The following data is part of a premarket notification filed by D. E. Hokanson, Inc. with the FDA for Ob1 Obstetrical Doppler.
| Device ID | K033156 |
| 510k Number | K033156 |
| Device Name: | OB1 OBSTETRICAL DOPPLER |
| Classification | Monitor, Ultrasonic, Fetal |
| Applicant | D. E. HOKANSON, INC. 12840 N.E. 21ST PL. Bellevue, WA 98005 -1910 |
| Contact | D. Eugene Hokanson |
| Correspondent | D. Eugene Hokanson D. E. HOKANSON, INC. 12840 N.E. 21ST PL. Bellevue, WA 98005 -1910 |
| Product Code | KNG |
| CFR Regulation Number | 884.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-09-30 |
| Decision Date | 2003-12-09 |
| Summary: | summary |