OMNI TENS— 510(k) K821523

Substantially Equivalent

Omni Intl., Inc.

FDA 510(k) clearance K821523 for OMNI TENS, Substantially Equivalent on 1982-06-16. Applicant: Omni Intl., Inc.. Device class: 2.

Clearance details

Applicant: Omni Intl., Inc.
Product code: Code GZJ
Device class: Class 2
Regulation: 21 CFR 882.5890
Advisory panel: Neurology
Date received: 1982-05-21
Decision date: 1982-06-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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More clearances from Omni Intl., Inc.

K984066 — OMNIGRIP, LATEX SURGICAL GLOVE, POWDER-FREE WITH PROTEIN LABELING CLAIM1999-01-13
K984064 — OMNIGRIP, LATEX SURGICAL GLOVE, POWDER FREE1999-01-08
K853255 — OMNIMED I.V. SOLUTION ADMIN. SET1985-08-23
K851938 — OMNIMED SURGICAL GOWN1985-06-28
K851654 — OMNIMED CLAMP1985-05-31

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