The following data is part of a premarket notification filed by Infinite Biomedical Technologies, Llc with the FDA for Sense System With Ibt Electrodes.
| Device ID | K182112 |
| 510k Number | K182112 |
| Device Name: | Sense System With IBT Electrodes |
| Classification | Electrode, Cutaneous |
| Applicant | Infinite Biomedical Technologies, LLC 8 Market Place, Suite 500 Baltimore, MD 21202 |
| Contact | Rahul Kaliki |
| Correspondent | Rahul Kaliki Infinite Biomedical Technologies, LLC 8 Market Place, Suite 500 Baltimore, MD 21202 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-08-06 |
| Decision Date | 2018-10-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850004850480 | K182112 | 000 |
| 00850004850206 | K182112 | 000 |
| 00850004850190 | K182112 | 000 |
| 00850004850169 | K182112 | 000 |
| 00850004850152 | K182112 | 000 |
| 00850004850145 | K182112 | 000 |
| 00850004850138 | K182112 | 000 |
| 00850004850121 | K182112 | 000 |
| 00850004850114 | K182112 | 000 |
| 00850004850107 | K182112 | 000 |
| 00850004850091 | K182112 | 000 |
| 00850004850084 | K182112 | 000 |
| 00850004850077 | K182112 | 000 |
| 00850004850060 | K182112 | 000 |
| 00850004850053 | K182112 | 000 |
| 00850004850046 | K182112 | 000 |
| 00850004850039 | K182112 | 000 |
| 00850004850183 | K182112 | 000 |
| 00850004850213 | K182112 | 000 |
| 00850004850220 | K182112 | 000 |
| 00850004850473 | K182112 | 000 |
| 00850004850466 | K182112 | 000 |
| 00850004850459 | K182112 | 000 |
| 00850004850442 | K182112 | 000 |
| 00850004850411 | K182112 | 000 |
| 00850004850404 | K182112 | 000 |
| 00850004850374 | K182112 | 000 |
| 00850004850343 | K182112 | 000 |
| 00850004850336 | K182112 | 000 |
| 00850004850329 | K182112 | 000 |
| 00850004850305 | K182112 | 000 |
| 00850004850299 | K182112 | 000 |
| 00850004850282 | K182112 | 000 |
| 00850004850268 | K182112 | 000 |
| 00850004850251 | K182112 | 000 |
| 00850004850244 | K182112 | 000 |
| 00850004850237 | K182112 | 000 |
| 00850004850176 | K182112 | 000 |