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 |