COM-TENS (SINGLE MODE)— 510(k) K931570

Substantially Equivalent

Ems Dist.

FDA 510(k) clearance K931570 for COM-TENS (SINGLE MODE), Substantially Equivalent on 1993-06-18. Applicant: Ems Dist.. Device class: 2.

Clearance details

Applicant: Ems Dist.
Product code: Code GZJ
Device class: Class 2
Regulation: 21 CFR 882.5890
Advisory panel: Neurology
Date received: 1993-03-30
Decision date: 1993-06-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pen Valley, CA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Ems Dist.

K921813 — MED-TENS1992-09-11
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Data sourced from openFDA. This site is unofficial and independent of the FDA.