The following data is part of a premarket notification filed by Path Medical Gmbh with the FDA for Earprobe.
| Device ID | K131141 |
| 510k Number | K131141 |
| Device Name: | EARPROBE |
| Classification | Stimulator, Auditory, Evoked Response |
| Applicant | PATH MEDICAL GMBH LANDSBERGER STR 63 Germering, Bavaria, DE D-82110 |
| Contact | Johann Oswald |
| Correspondent | Johann Oswald PATH MEDICAL GMBH LANDSBERGER STR 63 Germering, Bavaria, DE D-82110 |
| Product Code | GWJ |
| CFR Regulation Number | 882.1900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-04-23 |
| Decision Date | 2013-06-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04260223144936 | K131141 | 000 |
| 04260223144929 | K131141 | 000 |
| 04260223144684 | K131141 | 000 |