The following data is part of a premarket notification filed by E-z-em, Inc. with the FDA for Cysto-aid.
| Device ID | K841197 |
| 510k Number | K841197 |
| Device Name: | CYSTO-AID |
| Classification | Collector, Urine, (and Accessories) For Indwelling Catheter |
| Applicant | E-Z-EM, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KNX |
| CFR Regulation Number | 876.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-03-21 |
| Decision Date | 1984-07-09 |