Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K050496
Device Classification Name
Calibrator, Hearing Aid / Earphone And Analysis Systems
More FDA Info for this Device
510(K) Number
K050496
Device Name
Calibrator, Hearing Aid / Earphone And Analysis Systems
Applicant
INTERACOUSTICS A/S, ASSENS
9675 WEST 76TH ST.
EDEN PRAIRIE, MN 55344 US
Other 510(k) Applications for this Company
Contact
DANIEL EGGAN
Other 510(k) Applications for this Contact
Regulation Number
874.3310
More FDA Info for this Regulation Number
Classification Product Code
ETW
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/28/2005
Decision Date
04/29/2005
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
EN - Ear, Nose, & Throat
Review Advisory Committee
EN - Ear, Nose, & Throat
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact