The following data is part of a premarket notification filed by Resmed Ltd. with the FDA for Darlinghurst Vented, Darlinghurst Nv-aav.
| Device ID | K143603 |
| 510k Number | K143603 |
| Device Name: | Darlinghurst Vented, Darlinghurst NV-AAV |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | RESMED LTD. 1 ELIZABETH MACARTHUR DR Bella Vista, AU 2153 |
| Contact | Jean-nicholas Boudaud |
| Correspondent | Larissa D'andrea RESMED CORP. 9001 SPECTRUM CENTER BOULEVARD 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 | 2014-12-18 |
| Decision Date | 2015-05-21 |
| Summary: | summary |