The following data is part of a premarket notification filed by Ics Medical Corp. with the FDA for Ics Medical Chartr Ep And Chartr Oae Systems.
| Device ID | K002985 |
| 510k Number | K002985 |
| Device Name: | ICS MEDICAL CHARTR EP AND CHARTR OAE SYSTEMS |
| Classification | Stimulator, Auditory, Evoked Response |
| Applicant | ICS MEDICAL CORP. 125 COMMERCE DR. Schaumburg, IL 60173 -5329 |
| Contact | Delmar F Bloem |
| Correspondent | Delmar F Bloem ICS MEDICAL CORP. 125 COMMERCE DR. Schaumburg, IL 60173 -5329 |
| Product Code | GWJ |
| CFR Regulation Number | 882.1900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-09-25 |
| Decision Date | 2000-12-13 |