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 |
00849593015790 | K072016 | 000 |
00849593025560 | K072016 | 000 |
00849593025553 | K072016 | 000 |
00849593025546 | K072016 | 000 |
00849593025539 | K072016 | 000 |
00849593025522 | K072016 | 000 |
00849593025515 | K072016 | 000 |
00849593025133 | K072016 | 000 |
00849593025140 | K072016 | 000 |
00849593025232 | K072016 | 000 |
00849593025225 | K072016 | 000 |
00849593025201 | K072016 | 000 |
00849593025195 | K072016 | 000 |
00849593025188 | K072016 | 000 |
00849593025171 | K072016 | 000 |
00849593025164 | K072016 | 000 |
00849593025157 | K072016 | 000 |
00849593025607 | K072016 | 000 |