SCHULDT* PLUS 8 T.E.N.S. DEVICE— 510(k) K864368

Name: FDA 510(k) clearance K864368
Creator: U.S. Food and Drug Administration
Published: 1987-02-26

Substantially Equivalent

Schuldt Laboratories, Inc.

FDA 510(k) clearance K864368 for SCHULDT* PLUS 8 T.E.N.S. DEVICE, Substantially Equivalent on 1987-02-26. Applicant: Schuldt Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Schuldt Laboratories, Inc.
Product code: Code GZJ
Device class: Class 2
Regulation: 21 CFR 882.5890
Advisory panel: Neurology
Date received: 1986-11-05
Decision date: 1987-02-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Canada V1y 2g4, CA

Download summary PDF View on FDA.gov ↗

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