MODIFICATION TO:APEX MEDICAL IF-4100— 510(k) K013813

Substantially Equivalent

Apex Medical Corp.

FDA 510(k) clearance K013813 for MODIFICATION TO:APEX MEDICAL IF-4100, Substantially Equivalent on 2001-12-14. Applicant: Apex Medical Corp.. Device class: 2.

Clearance details

Applicant
Apex Medical Corp.
Product code
Code GXY
Device class
Class 2
Regulation
21 CFR 882.1320
Advisory panel
Neurology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Shi-Chih, Taipei Hsien, TW
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