THOMAS MEDICAL ELECTRODES— 510(k) K022593

Substantially Equivalent

Thomas Medical, Inc.

FDA 510(k) clearance K022593 for THOMAS MEDICAL ELECTRODES, Substantially Equivalent on 2002-11-01. Applicant: Thomas Medical, Inc.. Device class: 2.

Clearance details

Applicant
Thomas Medical, Inc.
Product code
Code HGI
Device class
Class 2
Regulation
21 CFR 884.4120
Advisory panel
Obstetrics/Gynecology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Alpharetta, GA, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code HGI

product code HGI
Other
1
Total
1

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.