Device Classification Name |
couch, radiation therapy, powered
|
510(k) Number |
K132084 |
Device Name |
PROTURA COUCH SOFTWARE |
Applicant |
MED-TEC, INC. D/B/A CIVCO MEDICAL SOLUTIONS |
1401 8TH STREET SE |
ORANGE CITY,
IA
51041
|
|
Applicant Contact |
AMANDA STAHLE |
Correspondent |
MED-TEC, INC. D/B/A CIVCO MEDICAL SOLUTIONS |
1401 8TH STREET SE |
ORANGE CITY,
IA
51041
|
|
Correspondent Contact |
AMANDA STAHLE |
Regulation Number | 892.5770
|
Classification Product Code |
|
Date Received | 07/05/2013 |
Decision Date | 09/26/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|