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 |