The following data is part of a premarket notification filed by Technomed Europe with the FDA for Cup Electrodes, Gold, Reusable, Silver, Reusable; Cup Electrodes Silver/silver Chloride Reusable.
| Device ID | K072016 |
| 510k Number | K072016 |
| Device Name: | CUP ELECTRODES, GOLD, REUSABLE, SILVER, REUSABLE; CUP ELECTRODES SILVER/SILVER CHLORIDE REUSABLE |
| Classification | Electrode, Cutaneous |
| Applicant | TECHNOMED EUROPE AMERIKALAAN 71 Maastricht Airport, NL 6199 Ae |
| Contact | Maurice Roost |
| Correspondent | Maurice Roost TECHNOMED EUROPE AMERIKALAAN 71 Maastricht Airport, NL 6199 Ae |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-07-23 |
| Decision Date | 2007-10-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00849593025249 | K072016 | 000 |
| 00084959302521 | K072016 | 000 |
| 00849593025133 | K072016 | 000 |
| 00849593025140 | K072016 | 000 |
| 00849593025157 | K072016 | 000 |
| 00849593025164 | K072016 | 000 |
| 00849593025171 | K072016 | 000 |
| 00849593025188 | K072016 | 000 |
| 00849593025195 | K072016 | 000 |
| 00849593025201 | K072016 | 000 |
| 00849593025225 | K072016 | 000 |
| 00849593025232 | K072016 | 000 |
| 00849593015790 | K072016 | 000 |