TRANS-PULSE MODEL #1103— 510(k) K862355

Substantially Equivalent

The Sun Co.

FDA 510(k) clearance K862355 for TRANS-PULSE MODEL #1103, Substantially Equivalent on 1986-08-19. Applicant: The Sun Co.. Device class: 2.

Clearance details

Applicant: The Sun Co.
Product code: Code GZJ
Device class: Class 2
Regulation: 21 CFR 882.5890
Advisory panel: Neurology
Date received: 1986-06-23
Decision date: 1986-08-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tampa, 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.