The following data is part of a premarket notification filed by Healthdyne, Inc. with the FDA for Model 16800 Trend Recorder.
| Device ID | K821612 |
| 510k Number | K821612 |
| Device Name: | MODEL 16800 TREND RECORDER |
| Classification | Recorder, Paper Chart |
| Applicant | HEALTHDYNE, 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 | 1982-06-02 |
| Decision Date | 1982-07-14 |