APEX MEDICAL DIGITAL EMS TS1311, TS1312— 510(k) K021754

Name: FDA 510(k) clearance K021754
Creator: U.S. Food and Drug Administration
Published: 2002-06-28

Substantially Equivalent

Apex Medical Corp.

FDA 510(k) clearance K021754 for APEX MEDICAL DIGITAL EMS TS1311, TS1312, Substantially Equivalent on 2002-06-28. 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: 2002-05-29
Decision date: 2002-06-28
Decision: Substantially Equivalent
Clearance type: Special
Location: Shi-Chih, Taipei Hsien, TW

Download summary PDF View on FDA.gov ↗

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