The following data is part of a premarket notification filed by Sunbeam Appliance Service Co. with the FDA for Sunbeam Dura-vap Warm Steam Vaporizer Model 1380.
| Device ID | K871189 |
| 510k Number | K871189 |
| Device Name: | SUNBEAM DURA-VAP WARM STEAM VAPORIZER MODEL 1380 |
| Classification | Humidifier, Non-direct Patient Interface (home-use) |
| Applicant | SUNBEAM APPLIANCE SERVICE CO. P.O. BOX 1570 1333 BUTTERFIELD RD. Downers Grove, IL 60515 |
| Contact | Uhl |
| Correspondent | Uhl SUNBEAM APPLIANCE SERVICE CO. P.O. BOX 1570 1333 BUTTERFIELD RD. Downers Grove, IL 60515 |
| Product Code | KFZ |
| CFR Regulation Number | 868.5460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-03-24 |
| Decision Date | 1987-05-08 |