ABLE-X— 510(k) K120783

Substantially Equivalent

Im-Able, Ltd.

FDA 510(k) clearance K120783 for ABLE-X, Substantially Equivalent on 2012-06-20. Applicant: Im-Able, Ltd.. Device class: 1.

Clearance details

Applicant: Im-Able, Ltd.
Product code: Code ION
Device class: Class 1
Regulation: 21 CFR 890.5370
Advisory panel: Physical Medicine
Date received: 2012-03-15
Decision date: 2012-06-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Palos Verdes Estates, 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.