ZEOBI— 510(k) K121338

Substantially Equivalent

Ivivi Health Science, LLC

FDA 510(k) clearance K121338 for ZEOBI, Substantially Equivalent on 2012-07-27. Applicant: Ivivi Health Science, LLC. Device class: 2.

Clearance details

Applicant: Ivivi Health Science, LLC
Product code: Code ILX
Device class: Class 2
Regulation: 21 CFR 890.5290
Advisory panel: Physical Medicine
Date received: 2012-05-03
Decision date: 2012-07-27
Decision: Substantially Equivalent
Clearance type: Special
Location: San Francisco, CA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.