The following data is part of a premarket notification filed by Diamond Orthotic Laboratory with the FDA for Diamond Digital Sleep Orthotic (ddso).
| Device ID | K202499 |
| 510k Number | K202499 |
| Device Name: | Diamond Digital Sleep Orthotic (DDSO) |
| Classification | Device, Anti-snoring |
| Applicant | Diamond Orthotic Laboratory 7859 El Cajon Blvd. La Mesa, CA 91942 |
| Contact | Matt Rago |
| Correspondent | Dave Yungvurt THIRD PARTY REVIEW GROUP, LLC 25 Independence Blvd Warren, NJ 07059 |
| Product Code | LRK |
| CFR Regulation Number | 872.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2020-08-31 |
| Decision Date | 2020-09-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860005253807 | K202499 | 000 |