The following data is part of a premarket notification filed by Resmed Ltd. with the FDA for Geo.
| Device ID | K121705 |
| 510k Number | K121705 |
| Device Name: | GEO |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | RESMED LTD. 9001 SPECTRUM CENTER BLVD. San Diego, CA 92123 |
| Contact | Jim Cassi |
| Correspondent | Jim Cassi 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 | 2012-06-08 |
| Decision Date | 2012-10-23 |
| Summary: | summary |