The following data is part of a premarket notification filed by Elmed, Inc. with the FDA for Elmed Esu 120 M/m Digital.
| Device ID | K974793 |
| 510k Number | K974793 |
| Device Name: | ELMED ESU 120 M/M 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 | 1997-12-22 |
| Decision Date | 1998-03-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842180190948 | K974793 | 000 |
| B382SD47520010DM450 | K974793 | 000 |
| B382SD47520010DM800 | K974793 | 000 |
| B382SD475200625F0 | K974793 | 000 |
| B382SD47520083SS0 | K974793 | 000 |
| B382SD47520085B0 | K974793 | 000 |
| B382SD47520095A0 | K974793 | 000 |
| B382SD47520095D0 | K974793 | 000 |
| B382SD4915000 | K974793 | 000 |
| B382SD509S0 | K974793 | 000 |
| B382SD5200 | K974793 | 000 |
| B382SD52005180 | K974793 | 000 |
| B382SD52005230 | K974793 | 000 |
| B382SD52005240 | K974793 | 000 |
| B382SD52260 | K974793 | 000 |
| B382SD4752001050 | K974793 | 000 |
| B382SD475200103SS0 | K974793 | 000 |
| 00842180191327 | K974793 | 000 |
| 00842180164604 | K974793 | 000 |
| 00842180164956 | K974793 | 000 |
| 00842180164963 | K974793 | 000 |
| B382SD373000 | K974793 | 000 |
| B382SD4511030 | K974793 | 000 |
| B382SD4751000930 | K974793 | 000 |
| B382SD4751000940 | K974793 | 000 |
| B382SD475200082SS0 | K974793 | 000 |
| B382SD475200084SS0 | K974793 | 000 |
| B382SD475200086SS0 | K974793 | 000 |
| B382SD47520009DM150 | K974793 | 000 |
| B382SD4752001030 | K974793 | 000 |
| B382SD475200103120 | K974793 | 000 |
| B382SD5230 | K974793 | 000 |
| B382SD52300 | K974793 | 000 |
| B382SD5300 | K974793 | 000 |
| B382SD5600 | K974793 | 000 |
| B382SD76820 | K974793 | 000 |
| B382SD773090 | K974793 | 000 |
| B382SD78200 | K974793 | 000 |
| B382SD847090 | K974793 | 000 |
| B382SDS4550B0 | K974793 | 000 |
| B382SD0107A0 | K974793 | 000 |
| B382SD1107A0 | K974793 | 000 |
| B382SD50180 | K974793 | 000 |
| B382SD60180 | K974793 | 000 |
| B382SD60230 | K974793 | 000 |
| B382SD82430340 | K974793 | 000 |
| B382SD84880 | K974793 | 000 |
| B382SD940080 | K974793 | 000 |
| B382SD5480 | K974793 | 000 |
| B382SD5390 | K974793 | 000 |
| B382SD5310 | K974793 | 000 |
| B382SD5320 | K974793 | 000 |
| B382SD532M0 | K974793 | 000 |
| B382SD5400 | K974793 | 000 |
| B382SD5401100 | K974793 | 000 |
| B382SD5440 | K974793 | 000 |
| B382SD5450 | K974793 | 000 |
| B382SD5460 | K974793 | 000 |
| B382SD5470 | K974793 | 000 |
| B382SD550130 | K974793 | 000 |
| B382SD550140 | K974793 | 000 |
| B382SD5610 | K974793 | 000 |
| B382SD5090 | K974793 | 000 |
| B382SD5290 | K974793 | 000 |
| B382SD941050 | K974793 | 000 |