The following data is part of a premarket notification filed by Iti Medical Technologies, Inc. with the FDA for Midas Touch Electrosurgical Electrode.
| Device ID | K973234 |
| 510k Number | K973234 |
| Device Name: | MIDAS TOUCH ELECTROSURGICAL ELECTRODE |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | ITI MEDICAL TECHNOLOGIES, INC. 2452 ARMSTRONG ST. Livermore, CA 94550 |
| Contact | Roger Werne |
| Correspondent | Roger Werne ITI MEDICAL TECHNOLOGIES, INC. 2452 ARMSTRONG ST. Livermore, CA 94550 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-08-28 |
| Decision Date | 1997-10-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30841785106386 | K973234 | 000 |
| 30841785106263 | K973234 | 000 |
| 30841785106256 | K973234 | 000 |
| 30841785106232 | K973234 | 000 |
| 30841785106225 | K973234 | 000 |
| 30841785106218 | K973234 | 000 |
| 30841785106201 | K973234 | 000 |
| 30841785106195 | K973234 | 000 |
| 30841785106188 | K973234 | 000 |
| 30841785106171 | K973234 | 000 |
| 30841785106270 | K973234 | 000 |
| 30841785106287 | K973234 | 000 |
| 30841785106379 | K973234 | 000 |
| 30841785106362 | K973234 | 000 |
| 30841785106355 | K973234 | 000 |
| 30841785106348 | K973234 | 000 |
| 30841785106331 | K973234 | 000 |
| 30841785106324 | K973234 | 000 |
| 30841785106317 | K973234 | 000 |
| 30841785106300 | K973234 | 000 |
| 30841785106294 | K973234 | 000 |
| 30841785106164 | K973234 | 000 |