Device Classification Name |
tester, auditory impedance
|
510(k) Number |
K031978 |
Device Name |
AMPLAID A756 SCREENING ADMITTANCE METER |
Applicant |
AMPLAID |
PO BOX 7007 |
DEERFIELD,
IL
60015
|
|
Applicant Contact |
DANIEL KAMM |
Correspondent |
AMPLAID |
PO BOX 7007 |
DEERFIELD,
IL
60015
|
|
Correspondent Contact |
DANIEL KAMM |
Regulation Number | 874.1090
|
Classification Product Code |
|
Date Received | 06/26/2003 |
Decision Date | 07/21/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|