The following data is part of a premarket notification filed by Waters Assoc., Inc. with the FDA for Data Module.
| Device ID | K781915 |
| 510k Number | K781915 |
| Device Name: | DATA MODULE |
| Classification | Apparatus, High Pressure Liquid Chromatography |
| Applicant | WATERS ASSOC., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KIE |
| CFR Regulation Number | 862.2260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-11-14 |
| Decision Date | 1979-01-10 |