Device Classification Name |
System, Imaging, Pulsed Doppler, Ultrasonic
|
510(k) Number |
K122009 |
Device Name |
AIDA VI.8 DIAGNOSTIC ULTRASOUND GM-72P00A, L13-5V1 TRANSDUCER |
Applicant |
PANASONIC HEALTHCARE CO., LTD. |
2425 SQUAK MOUNTAIN LOOP SW |
ISSAQUAH,
WA
98027
|
|
Applicant Contact |
RAM BEDI |
Correspondent |
PANASONIC HEALTHCARE CO., LTD. |
2425 SQUAK MOUNTAIN LOOP SW |
ISSAQUAH,
WA
98027
|
|
Correspondent Contact |
RAM BEDI |
Regulation Number | 892.1550
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 07/09/2012 |
Decision Date | 10/03/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|