The following data is part of a premarket notification filed by Medasonics, Inc. with the FDA for Model R11 Single Channel Chart Recorder.
| Device ID | K801549 |
| 510k Number | K801549 |
| Device Name: | MODEL R11 SINGLE CHANNEL CHART RECORDER |
| Classification | Recorder, Paper Chart |
| Applicant | MEDASONICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DSF |
| CFR Regulation Number | 870.2810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-07-07 |
| Decision Date | 1980-07-14 |