The following data is part of a premarket notification filed by Resmed Ltd. with the FDA for Mirage Micro Model 16333 (s), 16334 (m&l), 16335 (lw & Xl).
| Device ID | K100772 |
| 510k Number | K100772 |
| Device Name: | MIRAGE MICRO MODEL 16333 (S), 16334 (M&L), 16335 (LW & XL) |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-03-18 |
| Decision Date | 2010-06-09 |