The following data is part of a premarket notification filed by E-z-em, Inc. with the FDA for Protoco2l Colon Insufflator With Performance Improvements, Model 6400.
| Device ID | K030854 |
| 510k Number | K030854 |
| Device Name: | PROTOCO2L COLON INSUFFLATOR WITH PERFORMANCE IMPROVEMENTS, MODEL 6400 |
| Classification | Insufflator, Automatic Carbon-dioxide For Endoscope |
| Applicant | E-Z-EM, INC. 717 MAIN ST. Westbury, NY 11590 |
| Contact | Judy Hauser |
| Correspondent | Judy Hauser E-Z-EM, INC. 717 MAIN ST. Westbury, NY 11590 |
| Product Code | FCX |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-03-18 |
| Decision Date | 2003-04-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30815112020799 | K030854 | 000 |
| 10815112020139 | K030854 | 000 |
| 30815112021130 | K030854 | 000 |
| 30815112021574 | K030854 | 000 |
| 30815112021253 | K030854 | 000 |
| 30815112021291 | K030854 | 000 |
| 30815112021260 | K030854 | 000 |
| 30815112021284 | K030854 | 000 |
| 10815112020160 | K030854 | 000 |
| 30815112020171 | K030854 | 000 |
| 30815112020188 | K030854 | 000 |
| 30815112020126 | K030854 | 000 |