The following data is part of a premarket notification filed by Elmed, Inc. with the FDA for Electrosurgical Units Esu 30, 70, 70 B, 70 Digital.
| Device ID | K915731 |
| 510k Number | K915731 |
| Device Name: | ELECTROSURGICAL UNITS ESU 30, 70, 70 B, 70 DIGITAL |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | ELMED, INC. 60 WEST FAY AVE. Addison, IL 60101 |
| Contact | Werner Hausner |
| Correspondent | Werner Hausner ELMED, INC. 60 WEST FAY AVE. Addison, IL 60101 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-12-20 |
| Decision Date | 1992-11-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842180163263 | K915731 | 000 |
| 00842180166059 | K915731 | 000 |