The following data is part of a premarket notification filed by United States Endoscopy Group, Inc with the FDA for Aquashield System Co2, Aquashield System Co2-pentax, Aquashield System Co2-fujifilm.
| Device ID | K191559 |
| 510k Number | K191559 |
| Device Name: | AquaShield System CO2, AquaShield System CO2-PENTAX, AquaShield System CO2-FUJIFILM |
| Classification | Pump, Air, Non-manual, For Endoscope |
| Applicant | United States Endoscopy Group, Inc 5976 Heisley Road Mentor, OH 44060 |
| Contact | Carroll Martin |
| Correspondent | Carroll Martin United States Endoscopy Group, Inc 5976 Heisley Road Mentor, OH 44060 |
| Product Code | FEQ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-13 |
| Decision Date | 2019-08-01 |