The following data is part of a premarket notification filed by Bourns Medical Systems, Inc. with the FDA for Humidifiers, Model:ls-420 And Ls-460.
| Device ID | K781760 |
| 510k Number | K781760 |
| Device Name: | HUMIDIFIERS, MODEL:LS-420 AND LS-460 |
| Classification | Humidifier, Respiratory Gas, (direct Patient Interface) |
| Applicant | BOURNS MEDICAL SYSTEMS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | BTT |
| CFR Regulation Number | 868.5450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-10-16 |
| Decision Date | 1978-12-20 |