Submission Details
| 510(k) Number | K073532 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 17, 2007 |
| Decision Date | May 01, 2008 |
| Days to Decision | 136 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
Cleared
Traditional
DISPOSABLE ADHESIVE SURFACE ELECTRODES, DISC ELECTRODES
May 2008
Decision
136d
Days
Class 2
Risk
About This 510(k) Submission
K073532 is an FDA 510(k) clearance for the DISPOSABLE ADHESIVE SURFACE ELECTRODES, DISC ELECTRODES, a Electrode, Cutaneous (Class II — Special Controls, product code GXY), submitted by Technomed Europe (Maastricht-Airport, NL). The FDA issued a Cleared decision on May 1, 2008, 136 days after receiving the submission on December 17, 2007. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1320.
Device Classification
| Product Code | GXY — Electrode, Cutaneous |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 882.1320 |
Manufacturer
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