The following data is part of a premarket notification filed by Path Medical Gmbh with the FDA for Earprobe.
| Device ID | K100661 |
| 510k Number | K100661 |
| Device Name: | EARPROBE |
| Classification | Stimulator, Auditory, Evoked Response |
| Applicant | PATH MEDICAL GMBH 4120 PICADILLY DRIVE Fort Collins, CO 80526 |
| Contact | Kurt Rentel |
| Correspondent | Kurt Rentel PATH MEDICAL GMBH 4120 PICADILLY DRIVE Fort Collins, CO 80526 |
| Product Code | GWJ |
| CFR Regulation Number | 882.1900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-03-08 |
| Decision Date | 2010-07-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04260223146022 | K100661 | 000 |