PULSETTE 110 TRANSCUTANEOUS ELEC-NERVE— 510(k) K830792

Name: FDA 510(k) clearance K830792
Creator: U.S. Food and Drug Administration
Published: 1983-03-29

Substantially Equivalent

Bomed Medical Mfr., Ltd.

FDA 510(k) clearance K830792 for PULSETTE 110 TRANSCUTANEOUS ELEC-NERVE, Substantially Equivalent on 1983-03-29. Applicant: Bomed Medical Mfr., Ltd.. Device class: 2.

Clearance details

Applicant: Bomed Medical Mfr., Ltd.
Product code: Code GZJ
Device class: Class 2
Regulation: 21 CFR 882.5890
Advisory panel: Neurology
Date received: 1983-03-14
Decision date: 1983-03-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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