K905545 is an FDA 510(k) clearance for the ULTRASOUND TRANSMISSION GEL. This device is classified as a Electrode, Gel, Electrosurgical (Class II - Special Controls, product code JOT).
Submitted by Arbo Medical, Inc. (Stratford, US). The FDA issued a Cleared decision on March 29, 1991, 108 days after receiving the submission on December 11, 1990.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4400.
| 510(k) Number | K905545 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 11, 1990 |
| Decision Date | March 29, 1991 |
| Days to Decision | 108 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | JOT — Electrode, Gel, Electrosurgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4400 |