The following data is part of a premarket notification filed by Path Medical Gmbh with the FDA for Algo 7i.
| Device ID | K211147 |
| 510k Number | K211147 |
| Device Name: | ALGO 7i |
| Classification | Stimulator, Auditory, Evoked Response |
| Applicant | Path Medical GmbH Landsberger Strasse 65 Germering, DE 82110 |
| Contact | Ing. Johann Oswald |
| Correspondent | Ing. Johann Oswald Path Medical GmbH Landsberger Strasse 65 Germering, DE 82110 |
| Product Code | GWJ |
| CFR Regulation Number | 882.1900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-04-19 |
| Decision Date | 2021-10-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04260223145490 | K211147 | 000 |
| 04260223145483 | K211147 | 000 |
| 04260223145476 | K211147 | 000 |
| 04260223145469 | K211147 | 000 |
| 04260223145421 | K211147 | 000 |
| 04260223145414 | K211147 | 000 |