ULTRA 2000 (T.E.N.S.)— 510(k) K884833

Substantially Equivalent

Maxima Intl., Inc.

FDA 510(k) clearance K884833 for ULTRA 2000 (T.E.N.S.), Substantially Equivalent on 1989-02-13. Applicant: Maxima Intl., Inc.. Device class: 2.

Clearance details

Applicant: Maxima Intl., Inc.
Product code: Code GZJ
Device class: Class 2
Regulation: 21 CFR 882.5890
Advisory panel: Neurology
Date received: 1988-11-18
Decision date: 1989-02-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, 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.