The following data is part of a premarket notification filed by Ad-tech Medical Instrument Corporation with the FDA for Fremap Electrode.
| Device ID | K152769 |
| 510k Number | K152769 |
| Device Name: | FREMAP ELECTRODE |
| Classification | Stimulator, Nerve |
| Applicant | AD-TECH MEDICAL INSTRUMENT CORPORATION 1901 WILLIAM STREET Racine, WI 53404 |
| Contact | Lisa Theama |
| Correspondent | Gary J. Syring QUALITY & REGULATORY ASSOCIATES, LLC 800 LEVANGER LANE Stoughton, WI 53589 |
| Product Code | ETN |
| CFR Regulation Number | 874.1820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-25 |
| Decision Date | 2016-05-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 90841823108480 | K152769 | 000 |