Device Classification Name |
audiometer
|
510(k) Number |
K903143 |
Device Name |
OTOSCREENER-I AND OTO-SCREEN-I-P |
Applicant |
HANDTRONIX, INC. |
2435 FALCON WAY |
SANDY,
UT
84093
|
|
Applicant Contact |
LYNN S ALVORD |
Correspondent |
HANDTRONIX, INC. |
2435 FALCON WAY |
SANDY,
UT
84093
|
|
Correspondent Contact |
LYNN S ALVORD |
Regulation Number | 874.1050
|
Classification Product Code |
|
Date Received | 07/18/1990 |
Decision Date | 09/19/1990 |
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
|
|
|