The following data is part of a premarket notification filed by Ga Health Company Limited with the FDA for Andorate Suction Valve, Andorate Air/water Valve.
| Device ID | K213095 |
| 510k Number | K213095 |
| Device Name: | Andorate Suction Valve, Andorate Air/Water Valve |
| Classification | Endoscope Channel Accessory |
| Applicant | GA Health Company Limited Unit 18, 21/F, Metropole Square, 2 On Yiu Street, Shatin Hong Kong, CN |
| Contact | Cindy Ye |
| Correspondent | Cindy Ye GA Health Company Limited Unit 18, 21/F, Metropole Square, 2 On Yiu Street, Shatin Hong Kong, CN |
| Product Code | ODC |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-24 |
| Decision Date | 2022-01-12 |