The following data is part of a premarket notification filed by Sedation Systems Llc with the FDA for Miniscav.
| Device ID | K160950 |
| 510k Number | K160950 |
| Device Name: | MINISCAV |
| Classification | Apparatus, Gas-scavenging |
| Applicant | Sedation Systems LLC 2471 McMullen Booth Rd, Ste. 316 Clearwater, FL 33759 |
| Contact | S. Michael Bender |
| Correspondent | Paul Dryden Sedation Systems LLC 2471 McMullen Booth Rd, Ste. 316 Clearwater, FL 33759 |
| Product Code | CBN |
| CFR Regulation Number | 868.5430 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-05 |
| Decision Date | 2017-05-05 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() MINISCAV 87089275 5259010 Live/Registered |
RA Medical Services Limited 2016-06-30 |