The following data is part of a premarket notification filed by Infinite Biomedical Technologies, Llc with the FDA for Element System With Ibt Electrodes.
| Device ID | K173571 |
| 510k Number | K173571 |
| Device Name: | Element System With IBT Electrodes |
| Classification | Electrode, Cutaneous |
| Applicant | Infinite Biomedical Technologies, LLC 1101 E 33rd Street Suite E305 Baltimore, MD 21218 |
| Contact | Rahul Kaliki |
| Correspondent | Rahul Kaliki Infinite Biomedical Technologies, LLC 1101 E 33rd Street Suite E305 Baltimore, MD 21218 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-11-20 |
| Decision Date | 2018-03-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850004850022 | K173571 | 000 |
| 00850004850008 | K173571 | 000 |