The following data is part of a premarket notification filed by Medical Imaging Systems, Inc. with the FDA for Barium Enema Tubes: No. 3001000, 3001001, 3001002.
| Device ID | K885092 |
| 510k Number | K885092 |
| Device Name: | BARIUM ENEMA TUBES: NO. 3001000, 3001001, 3001002 |
| Classification | Colonic Irrigation System |
| Applicant | MEDICAL IMAGING SYSTEMS, INC. 2605 CABOVER DRIVE, SUITE #11 Hanover, MD 21076 |
| Contact | Jerry J Ditzel |
| Correspondent | Jerry J Ditzel MEDICAL IMAGING SYSTEMS, INC. 2605 CABOVER DRIVE, SUITE #11 Hanover, MD 21076 |
| Product Code | KPL |
| CFR Regulation Number | 876.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-12-12 |
| Decision Date | 1989-03-10 |