Device Classification Name |
System, Tomography, Computed, Emission
|
510(k) Number |
K914807 |
Device Name |
APEX HELIX - A |
Applicant |
ELSCINT, INC. |
505 MAIN ST. |
SUITE 300 |
HACKENSACK,
NJ
07601
|
|
Applicant Contact |
ROCHELLE M SOBEL |
Correspondent |
ELSCINT, INC. |
505 MAIN ST. |
SUITE 300 |
HACKENSACK,
NJ
07601
|
|
Correspondent Contact |
ROCHELLE M SOBEL |
Regulation Number | 892.1200
|
Classification Product Code |
|
Date Received | 10/25/1991 |
Decision Date | 02/27/1992 |
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
|
|
|