MED-TENS— 510(k) K921813

Substantially Equivalent

Ems Dist.

FDA 510(k) clearance K921813 for MED-TENS, Substantially Equivalent on 1992-09-11. 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
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Pen Valley, CA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.