The following data is part of a premarket notification filed by E-z-em, Inc. with the FDA for E-z-flate.
| Device ID | K930581 |
| 510k Number | K930581 |
| Device Name: | E-Z-FLATE |
| Classification | Insufflator, Automatic Carbon-dioxide For Endoscope |
| Applicant | E-Z-EM, INC. 717 MAIN ST. Westbury, NY 11590 |
| Contact | Merribeth Adams |
| Correspondent | Merribeth Adams E-Z-EM, INC. 717 MAIN ST. Westbury, NY 11590 |
| Product Code | FCX |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-02-04 |
| Decision Date | 1994-07-01 |