The following data is part of a premarket notification filed by Penlon, Inc. with the FDA for Magtarak Respiratory Monitor & Flow Sens.
| Device ID | K823555 |
| 510k Number | K823555 |
| Device Name: | MAGTARAK RESPIRATORY MONITOR & FLOW SENS |
| Classification | Spirometer, Monitoring (w/wo Alarm) |
| Applicant | PENLON, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | BZK |
| CFR Regulation Number | 868.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-12-01 |
| Decision Date | 1983-01-05 |