The following data is part of a premarket notification filed by Resmed Ltd with the FDA for Juno Vpap St-a.
| Device ID | K153061 |
| 510k Number | K153061 |
| Device Name: | Juno VPAP ST-A |
| Classification | Ventilator, Continuous, Non-life-supporting |
| Applicant | RESMED LTD 1 Elizabeth Macarthur Drive Bella Vista, AU 2153 |
| Contact | Jean-nicolas Boudaud |
| 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 | 2015-10-21 |
| Decision Date | 2016-04-13 |
| Summary: | summary |