The following data is part of a premarket notification filed by Resmed Ltd. with the FDA for Mirage Swift.
Device ID | K042403 |
510k Number | K042403 |
Device Name: | MIRAGE SWIFT |
Classification | Ventilator, Non-continuous (respirator) |
Applicant | RESMED LTD. 14040 DANIELSON ST. Poway, CA 92064 -6857 |
Contact | David D'cruz |
Correspondent | David D'cruz RESMED LTD. 14040 DANIELSON ST. Poway, CA 92064 -6857 |
Product Code | BZD |
CFR Regulation Number | 868.5905 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-09-03 |
Decision Date | 2004-10-08 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
MIRAGE SWIFT 78333941 2945303 Dead/Cancelled |
ResMed Limited 2003-11-26 |
MIRAGE SWIFT 78333939 2945302 Live/Registered |
RESMED PTY LTD 2003-11-26 |