The following data is part of a premarket notification filed by Litton Medical Electronics with the FDA for Respiration Monitor.
| Device ID | K832999 | 
| 510k Number | K832999 | 
| Device Name: | RESPIRATION MONITOR | 
| Classification | Monitor, Apnea, Facility Use | 
| Applicant | LITTON MEDICAL ELECTRONICS 803 N. Front St. Suite 3 Mchenry, IL 60050 | 
| Product Code | FLS | 
| CFR Regulation Number | 868.2377 [🔎] | 
| Decision | Substantially Equivalent (SESE) | 
| Type | Traditional | 
| 3rd Party Reviewed | No | 
| Combination Product | No | 
| Date Received | 1983-08-18 | 
| Decision Date | 1984-02-13 |