Device Classification Name |
Transducer, Ultrasonic, Obstetric
|
510(k) Number |
K862072 |
Device Name |
FETASCAN ULTRASOUND TRANSDUCER IBI# 101B00054-01 |
Applicant |
INTERNATIONAL BIOMEDICS, INC. |
1631 220TH AVE. S.E. |
(PER DO, FIRM OOB) |
BOTHELL,
WA
98021
|
|
Applicant Contact |
HOCHBERG, MD |
Correspondent |
INTERNATIONAL BIOMEDICS, INC. |
1631 220TH AVE. S.E. |
(PER DO, FIRM OOB) |
BOTHELL,
WA
98021
|
|
Correspondent Contact |
HOCHBERG, MD |
Regulation Number | 884.2960
|
Classification Product Code |
|
Date Received | 05/30/1986 |
Decision Date | 07/09/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|