The following data is part of a premarket notification filed by E-z-em, Inc. with the FDA for E-z-em Endoscopic Co2 Regulator.
| Device ID | K053008 |
| 510k Number | K053008 |
| Device Name: | E-Z-EM ENDOSCOPIC CO2 REGULATOR |
| Classification | Insufflator, Automatic Carbon-dioxide For Endoscope |
| Applicant | E-Z-EM, INC. 750 SUMMA AVE. Westbury, NY 11590 |
| Contact | Robert Williams |
| Correspondent | Robert Williams E-Z-EM, INC. 750 SUMMA AVE. 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 | 2005-10-26 |
| Decision Date | 2005-12-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10816765013097 | K053008 | 000 |
| 00816765013151 | K053008 | 000 |
| 00724995180379 | K053008 | 000 |