The following data is part of a premarket notification filed by Electroscope, Inc. with the FDA for Electroscope Monitor, Em-1.
| Device ID | K913625 |
| 510k Number | K913625 |
| Device Name: | ELECTROSCOPE MONITOR, EM-1 |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | ELECTROSCOPE, INC. 4890 STERLING DR. Boulder, CO 80301 |
| Contact | Roger C Odell |
| Correspondent | Roger C Odell ELECTROSCOPE, INC. 4890 STERLING DR. Boulder, CO 80301 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-08-15 |
| Decision Date | 1991-12-30 |