The following data is part of a premarket notification filed by Sunset Healthcare Solutions, Inc. with the FDA for Sunset Heated Cpap Tube.
| Device ID | K201418 |
| 510k Number | K201418 |
| Device Name: | Sunset Heated CPAP Tube |
| Classification | Heater, Breathing System W/wo Controller (not Humidifier Or Nebulizer |
| Applicant | Sunset Healthcare Solutions, Inc. 180 N. Michigan Ave, Suite 2000 Chicago, IL 60601 |
| Contact | N. (nazree) Williams |
| Correspondent | Thomas Kroenke Speed To Market, Inc. 2235 East Flamingo Road, Suite 201G Las Vegas, NV 89119 |
| Product Code | BZE |
| CFR Regulation Number | 868.5270 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-05-29 |
| Decision Date | 2021-01-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10848530090606 | K201418 | 000 |
| 00848530102753 | K201418 | 000 |
| 00848530070670 | K201418 | 000 |