The following data is part of a premarket notification filed by Draeger Medical, Inc. with the FDA for Drager Sphygmomed.
| Device ID | K840162 |
| 510k Number | K840162 |
| Device Name: | DRAGER SPHYGMOMED |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | DRAEGER MEDICAL, INC. PA |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-01-13 |
| Decision Date | 1984-05-30 |