The following data is part of a premarket notification filed by Electroscope, Inc. with the FDA for Active Electrode Monitoring System.
| Device ID | K000480 |
| 510k Number | K000480 |
| Device Name: | ACTIVE ELECTRODE MONITORING SYSTEM |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | ELECTROSCOPE, INC. PO BOX 219 Indian Hills, CO 80454 |
| Contact | Lynne Aronson |
| Correspondent | Lynne Aronson ELECTROSCOPE, INC. PO BOX 219 Indian Hills, CO 80454 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-02-14 |
| Decision Date | 2000-05-02 |