The following data is part of a premarket notification filed by Resmed Ltd. with the FDA for Mirage Micro.
Device ID | K110444 |
510k Number | K110444 |
Device Name: | MIRAGE MICRO |
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 | 2011-02-16 |
Decision Date | 2011-03-16 |
Summary: | summary |