Device Classification Name |
Otoscope
|
510(k) Number |
K932259 |
Device Name |
CLARUS MODEL 2240 SEMI-RIGID OTOSCOPE |
Applicant |
CLARUS MEDICAL SYSTEMS, INC. |
2605 FERNBROOK LA |
MINNEAPOLIS,
MN
55447
|
|
Applicant Contact |
GREGORY J MATHISON |
Correspondent |
CLARUS MEDICAL SYSTEMS, INC. |
2605 FERNBROOK LA |
MINNEAPOLIS,
MN
55447
|
|
Correspondent Contact |
GREGORY J MATHISON |
Regulation Number | 874.4770
|
Classification Product Code |
|
Date Received | 04/20/1993 |
Decision Date | 12/15/1993 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|