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 |