Device Classification Name |
system, imaging, pulsed echo, ultrasonic
|
510(k) Number |
K802146 |
Device Name |
AQUASONIC 100 ULTRASOUND TRANS. GEL, |
Applicant |
PARKER LABORATORIES, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
PARKER LABORATORIES, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 892.1560
|
Classification Product Code |
|
Date Received | 09/05/1980 |
Decision Date | 10/10/1980 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|