The following data is part of a premarket notification filed by Bourns Medical Systems, Inc. with the FDA for Model Ls-80 Adult Ventilation Monitor.
| Device ID | K781515 |
| 510k Number | K781515 |
| Device Name: | MODEL LS-80 ADULT VENTILATION MONITOR |
| Classification | Monitor, Breathing Frequency |
| Applicant | BOURNS MEDICAL SYSTEMS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | BZQ |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-08-31 |
| Decision Date | 1978-10-02 |