The following data is part of a premarket notification filed by Aqua Medical, Inc. with the FDA for Rf Vapor System.
| Device ID | K213627 |
| 510k Number | K213627 |
| Device Name: | RF Vapor System |
| Classification | Unit, Electrosurgical, Endoscopic (with Or Without Accessories) |
| Applicant | Aqua Medical, Inc. 191 West Second St. Santa Ana, CA 92701 |
| Contact | Scott Mcgill |
| Correspondent | Bosmat Friedman ProMedoss, Inc. 3521 Hatwynn Rd. Charlotte, NC 28269 |
| Product Code | KNS |
| CFR Regulation Number | 876.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-11-17 |
| Decision Date | 2021-12-17 |