HIVOX Spopad EMS SP-911, SP-921— 510(k) K192264

Name: FDA 510(k) clearance K192264
Creator: U.S. Food and Drug Administration
Published: 2019-11-08

Substantially Equivalent

Hivox Biotek, Inc.

FDA 510(k) clearance K192264 for HIVOX Spopad EMS SP-911, SP-921, Substantially Equivalent on 2019-11-08. Applicant: Hivox Biotek, Inc.. Device class: 2.

Clearance details

Applicant: Hivox Biotek, Inc.
Product code: Code NGX
Device class: Class 2
Regulation: 21 CFR 890.5850
Advisory panel: Physical Medicine
Date received: 2019-08-21
Decision date: 2019-11-08
Decision: Substantially Equivalent
Clearance type: Special
Location: New Taipei City, TW

Download summary PDF View on FDA.gov ↗

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