Device Classification Name |
hearing aid, air-conduction, prescription
|
510(k) Number |
K933850 |
Device Name |
PHILIPS 45 SERIES |
Applicant |
PHILIPS HEARING INSTRUMENTS CO. |
91 MCKEE DR. |
MAHWAH,
NJ
07430
|
|
Applicant Contact |
ROBERT MARTIN |
Correspondent |
PHILIPS HEARING INSTRUMENTS CO. |
91 MCKEE DR. |
MAHWAH,
NJ
07430
|
|
Correspondent Contact |
ROBERT MARTIN |
Regulation Number | 874.3300
|
Classification Product Code |
|
Date Received | 08/06/1993 |
Decision Date | 09/07/1993 |
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
|
|
|