The following data is part of a premarket notification filed by Resmed Ltd. with the FDA for Swift Fx.
Device ID | K090244 |
510k Number | K090244 |
Device Name: | SWIFT FX |
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 | 2009-02-02 |
Decision Date | 2009-04-13 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
SWIFT FX 97632158 not registered Live/Pending |
Shenzhen Dengrui Trading Co., Ltd. 2022-10-14 |