The following data is part of a premarket notification filed by Rj & Vk Bird Pty Ltd. with the FDA for Anti-snoring/sleep Apnea Device.
| Device ID | K042161 |
| 510k Number | K042161 |
| Device Name: | ANTI-SNORING/SLEEP APNEA DEVICE |
| Classification | Device, Anti-snoring |
| Applicant | RJ & VK BIRD PTY LTD. 25 MILLS STREET Middle Park, Victoria, AU 3206 |
| Contact | Jonathon Bird |
| Correspondent | Jonathon Bird RJ & VK BIRD PTY LTD. 25 MILLS STREET Middle Park, Victoria, AU 3206 |
| Product Code | LRK |
| CFR Regulation Number | 872.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-08-10 |
| Decision Date | 2004-10-27 |
| Summary: | summary |