Device Classification Name |
System, Image Processing, Radiological
|
510(k) Number |
K014058 |
Device Name |
ENTEGRA PE PERSONAL DIGITAL ASSISTANT |
Applicant |
GENERAL ELECTRIC MEDICAL SYSTEMS |
3000 NORTH GRANDVIEW BLVD. |
WAUKESHA,
WI
53188
|
|
Applicant Contact |
D. DUERSTELER |
Correspondent |
TUV RHEINLAND OF NORTH AMERICA, INC. |
12 COMMERCE RD. |
NEWTON,
CT
06470
|
|
Correspondent Contact |
REINER KRUMME |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 12/10/2001 |
Decision Date | 12/21/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|