Device Classification Name |
Monitor, Ultrasonic, Fetal
|
510(k) Number |
K033156 |
Device Name |
OB1 OBSTETRICAL DOPPLER |
Applicant |
D. E. HOKANSON, INC. |
12840 N.E. 21ST PL. |
BELLEVUE,
WA
98005 -1910
|
|
Applicant Contact |
D. EUGENE HOKANSON |
Correspondent |
D. E. HOKANSON, INC. |
12840 N.E. 21ST PL. |
BELLEVUE,
WA
98005 -1910
|
|
Correspondent Contact |
D. EUGENE HOKANSON |
Regulation Number | 884.2660
|
Classification Product Code |
|
Date Received | 09/30/2003 |
Decision Date | 12/09/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|