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 | K182258 |
| 510k Number | K182258 |
| 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 L. Martin |
| Correspondent | Carroll L. 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 | 2018-08-21 |
| Decision Date | 2018-09-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10724995183858 | K182258 | 000 |
| 10724995183841 | K182258 | 000 |
| 10724995183827 | K182258 | 000 |