The following data is part of a premarket notification filed by Waters Assoc., Inc. with the FDA for Recorder, Re-100p Hot Stylus Strip Chart.
| Device ID | K780245 |
| 510k Number | K780245 |
| Device Name: | RECORDER, RE-100P HOT STYLUS STRIP CHART |
| Classification | Recorder, Paper Chart |
| Applicant | WATERS ASSOC., 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 | 1978-02-13 |
| Decision Date | 1978-03-27 |