The following data is part of a premarket notification filed by Smartguard Rx Inc. with the FDA for Smartguard Anti-snoring Device.
| Device ID | K200657 |
| 510k Number | K200657 |
| Device Name: | SmartGuard Anti-Snoring Device |
| Classification | Device, Anti-snoring |
| Applicant | SmartGuard Rx Inc. 2112 North Hill Field Rd. Suite 2A Layton, UT 84041 |
| Contact | Brian Larsen |
| Correspondent | Brian Larsen SmartGuard Rx Inc. 2112 North Hill Field Rd. Suite 2A Layton, UT 84041 |
| Product Code | LRK |
| CFR Regulation Number | 872.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-12 |
| Decision Date | 2021-08-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00866330000260 | K200657 | 000 |