Device Classification Name |
Ultrasound, Sinus
|
510(k) Number |
K960421 |
Device Name |
SINUSCAN 102/SINUSPRINT |
Applicant |
FERGUSON MEDICAL |
3407 BAY AVE. |
CHICO,
CA
95973 -8619
|
|
Applicant Contact |
FRANK FERGUSON |
Correspondent |
FERGUSON MEDICAL |
3407 BAY AVE. |
CHICO,
CA
95973 -8619
|
|
Correspondent Contact |
FRANK FERGUSON |
Regulation Number | 892.1560
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 01/29/1996 |
Decision Date | 04/16/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|