The following data is part of a premarket notification filed by Resmed Ltd. with the FDA for S9 Cronulla For Her.
| Device ID | K132606 |
| 510k Number | K132606 |
| Device Name: | S9 CRONULLA FOR HER |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | RESMED LTD. 9001 SPECTRUM CENTER BLVD Kearny Mesa, 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 | 2013-08-20 |
| Decision Date | 2014-01-13 |
| Summary: | summary |