MIRAGE QUATTRO
Ventilator, Non-continuous (respirator)
RESMED LTD.
The following data is part of a premarket notification filed by Resmed Ltd. with the FDA for Mirage Quattro.
Pre-market Notification Details
| Device ID | K113127 |
| 510k Number | K113127 |
| Device Name: | MIRAGE QUATTRO |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | RESMED LTD. 9001 SPECTRUM CENTER BLVD. San Diego, CA 92123 |
| Contact | David D'cruz |
| Correspondent | David D'cruz RESMED LTD. 9001 SPECTRUM CENTER BLVD. San Diego, CA 92123 |
| Product Code | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-10-24 |
| Decision Date | 2012-01-06 |
| Summary: | summary |
Trademark Results [MIRAGE QUATTRO]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MIRAGE QUATTRO 78972841 3318359 Live/Registered |
RESMED PTY LTD 2006-09-12 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.