K844098 is an FDA 510(k) clearance for the CANMED 103. This device is classified as a Electrode, Cutaneous (Class II - Special Controls, product code GXY).
Submitted by Medtronic Vascular (Lawrence, US). The FDA issued a Cleared decision on February 4, 1985, 104 days after receiving the submission on October 23, 1984.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1320.
| 510(k) Number | K844098 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 23, 1984 |
| Decision Date | February 04, 1985 |
| Days to Decision | 104 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | — |
| Product Code | GXY — Electrode, Cutaneous |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1320 |