The following data is part of a premarket notification filed by Dantec Medical, Inc. with the FDA for Dantec 13r45 Bar Electrode.
| Device ID | K934580 |
| 510k Number | K934580 |
| Device Name: | DANTEC 13R45 BAR ELECTRODE |
| Classification | Electrode, Cutaneous |
| Applicant | DANTEC MEDICAL, INC. 1575 EYE STREET, N.W. Washington, DC 20005 |
| Contact | Richard D Manthei |
| Correspondent | Richard D Manthei DANTEC MEDICAL, INC. 1575 EYE STREET, N.W. Washington, DC 20005 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-09-23 |
| Decision Date | 1994-09-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05704736000611 | K934580 | 000 |
| 05704736000598 | K934580 | 000 |
| 05704736000581 | K934580 | 000 |
| 05704736000567 | K934580 | 000 |
| 00382830047920 | K934580 | 000 |
| 00382830047913 | K934580 | 000 |
| 00382830047692 | K934580 | 000 |
| 00382830049559 | K934580 | 000 |
| 00382830048323 | K934580 | 000 |