INTERACOUSTICS ASSR, ECLIPSE SYSTEM (CABINET NAME)— 510(k) K070696

Substantially Equivalent

Interacoustics A/S

FDA 510(k) clearance K070696 for INTERACOUSTICS ASSR, ECLIPSE SYSTEM (CABINET NAME), Substantially Equivalent on 2007-06-29. Applicant: Interacoustics A/S. Device class: 2.

Clearance details

Applicant
Interacoustics A/S
Product code
Code GWJ
Device class
Class 2
Regulation
21 CFR 882.1900
Advisory panel
Neurology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Minnesota, MN, US
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