The following data is part of a premarket notification filed by United States Endoscopy Group, Inc. with the FDA for Aquashield Co2 System.
| Device ID | K120123 |
| 510k Number | K120123 |
| Device Name: | AQUASHIELD CO2 SYSTEM |
| Classification | Pump, Air, Non-manual, For Endoscope |
| Applicant | UNITED STATES ENDOSCOPY GROUP, INC. 5976 HEISLEY RD. Mentor, OH 44060 |
| Contact | Carroll L Martin |
| Correspondent | Carroll L Martin UNITED STATES ENDOSCOPY GROUP, INC. 5976 HEISLEY RD. Mentor, OH 44060 |
| Product Code | FEQ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-01-17 |
| Decision Date | 2012-03-28 |