The following data is part of a premarket notification filed by Inomed Medizintechnik Gmbh with the FDA for Mapping Suction Probe.
| Device ID | K212164 |
| 510k Number | K212164 |
| Device Name: | Mapping Suction Probe |
| Classification | Stimulator, Nerve |
| Applicant | inomed Medizintechnik GmbH Im Hausgruen 29 Emmendingen, DE 79312 |
| Contact | Alexander Maier |
| Correspondent | Shuofei Cheng inomed Medizintechnik GmbH Im Hausgruen 29 Emmendingen, DE 79312 |
| Product Code | ETN |
| CFR Regulation Number | 874.1820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-07-12 |
| Decision Date | 2022-11-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04250307602988 | K212164 | 000 |
| 14250307611413 | K212164 | 000 |