The following data is part of a premarket notification filed by E-z-em, Inc. with the FDA for Protoco2l Insufflator Model 6400.
| Device ID | K013219 |
| 510k Number | K013219 |
| Device Name: | PROTOCO2L INSUFFLATOR MODEL 6400 |
| Classification | Insufflator, Automatic Carbon-dioxide For Endoscope |
| Applicant | E-Z-EM, INC. 717 MAIN ST. Westbury, NY 11590 |
| Contact | Robert Williams |
| Correspondent | Robert Williams E-Z-EM, INC. 717 MAIN ST. Westbury, NY 11590 |
| Product Code | FCX |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-09-26 |
| Decision Date | 2002-02-19 |