The following data is part of a premarket notification filed by Aqua Medical, Inc. with the FDA for Rf Vapor System.
|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|
ProMedoss, Inc. 3521 Hatwynn Rd. Charlotte, NC 28269
|CFR Regulation Number||876.4300 [🔎]|
|Decision||Substantially Equivalent (SESE)|
|3rd Party Reviewed||No|