AEMS V, EMS-1000, MODEL TS-140500 AND AEMS VI, EMS-1000 PLUS, MODEL TS-140600— 510(k) K002339

Substantially Equivalent

Apex Medical Corp.

FDA 510(k) clearance K002339 for AEMS V, EMS-1000, MODEL TS-140500 AND AEMS VI, EMS-1000 PLUS, MODEL TS-140600, Substantially Equivalent on 2001-08-24. Applicant: Apex Medical Corp.. Device class: 2.

Clearance details

Applicant
Apex Medical Corp.
Product code
Code IPF
Device class
Class 2
Regulation
21 CFR 890.5850
Advisory panel
Physical Medicine
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Shi-Chih, Taipei Hsien, TW
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