The following data is part of a premarket notification filed by Ics Medical Corp. with the FDA for Automatic Caloric Irrigation System.
| Device ID | K881630 |
| 510k Number | K881630 |
| Device Name: | AUTOMATIC CALORIC IRRIGATION SYSTEM |
| Classification | Stimulator, Caloric-air |
| Applicant | ICS MEDICAL CORP. 2227 HAMMOND DR. Schaumburg, IL 60173 -3860 |
| Contact | Delmar F Bloem |
| Correspondent | Delmar F Bloem ICS MEDICAL CORP. 2227 HAMMOND DR. Schaumburg, IL 60173 -3860 |
| Product Code | KHH |
| CFR Regulation Number | 874.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-04-14 |
| Decision Date | 1988-06-21 |