The following data is part of a premarket notification filed by Resmed Ltd with the FDA for S9 Vpap Adapt, Vpap Adapt, Aircurve 10 Asv.
| Device ID | K160822 |
| 510k Number | K160822 |
| Device Name: | S9 VPAP Adapt, VPAP Adapt, AirCurve 10 ASV |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | RESMED LTD 1 ELIZABETH MACARTHUR DRIVE Bella Vista, AU 2153 |
| Contact | Jasjit Baveja |
| 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 | 2016-03-24 |
| Decision Date | 2016-09-09 |
| Summary: | summary |