The following data is part of a premarket notification filed by Resmed Ltd. with the FDA for Vpap Auto With Humidaire 3i.
| Device ID | K082605 |
| 510k Number | K082605 |
| Device Name: | VPAP AUTO WITH HUMIDAIRE 3I |
| 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 | 2008-09-08 |
| Decision Date | 2009-01-13 |
| Summary: | summary |