The following data is part of a premarket notification filed by Resmed Ltd. with the FDA for S8 Aspen With H4i Plus.
| Device ID | K091947 |
| 510k Number | K091947 |
| Device Name: | S8 ASPEN WITH H4I PLUS |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | RESMED LTD. 9001 SPECTRUM CENTER BLVD. San Diego, CA 92123 |
| Contact | David D'cruz |
| Correspondent | David D'cruz RESMED LTD. 9001 SPECTRUM CENTER BLVD. 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 | 2009-06-30 |
| Decision Date | 2009-09-28 |
| Summary: | summary |