Device Classification Name |
digitizer, image, radiological
|
510(k) Number |
K042484 |
Device Name |
NAI TECH PRODUCTS MEDICAL DIGITAL RECORDER |
Applicant |
NAI TECHNOLOGY PRODUCTS |
1342-D NORTH BENSON AVENUE |
UPLAND,
CA
91786
|
|
Applicant Contact |
ROBERT E JOHNSON |
Correspondent |
NAI TECHNOLOGY PRODUCTS |
1342-D NORTH BENSON AVENUE |
UPLAND,
CA
91786
|
|
Correspondent Contact |
ROBERT E JOHNSON |
Regulation Number | 892.2030
|
Classification Product Code |
|
Date Received | 09/13/2004 |
Decision Date | 10/20/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|