The following data is part of a premarket notification filed by Resmed Ltd. with the FDA for Swift Air.
Device ID | K132013 |
510k Number | K132013 |
Device Name: | SWIFT AIR |
Classification | Ventilator, Non-continuous (respirator) |
Applicant | RESMED LTD. 9001 SPECTRUM CENTER BLVD. San Diego, CA 92123 |
Contact | Jim Cassi |
Correspondent | Jim Cassi RESMED LTD. 9001 SPECTRUM CENTER BLVD. San Diego, CA 92123 |
Product Code | BZD |
CFR Regulation Number | 868.5905 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-07-01 |
Decision Date | 2013-10-21 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
SWIFT AIR 87816266 5555795 Live/Registered |
Swift Air, L.L.C. 2018-03-01 |