The following data is part of a premarket notification filed by Resmed Ltd with the FDA for Vpap Adapt Sv, Vpap Tx, S9 Vpap Tx.
| Device ID | K161487 |
| 510k Number | K161487 |
| Device Name: | VPAP Adapt SV, VPAP Tx, S9 VPAP Tx |
| Classification | Ventilator, Continuous, Non-life-supporting |
| Applicant | ResMed Ltd 1 Elizabeth Macarthur Drive Bella Vista, AU Nsw 2153 |
| Contact | Jasjit Baveja |
| Correspondent | Larissa D'andrea Resmed Corp 9001 Spectrum Center Boulevard San Diego, CA 92123 |
| Product Code | MNS |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-05-31 |
| Decision Date | 2016-09-09 |
| Summary: | summary |