The following data is part of a premarket notification filed by Resmed Ltd. with the FDA for Res Traxx Online, Model: R14.
| Device ID | K083816 |
| 510k Number | K083816 |
| Device Name: | RES TRAXX ONLINE, MODEL: R14 |
| 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 | 2008-12-22 |
| Decision Date | 2009-03-20 |
| Summary: | summary |