The following data is part of a premarket notification filed by Medex, Inc. with the FDA for Disposable Diaphragm Dome.
| Device ID | K810009 |
| 510k Number | K810009 |
| Device Name: | DISPOSABLE DIAPHRAGM DOME |
| Classification | Transducer, Blood-pressure, Extravascular |
| Applicant | MEDEX, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DRS |
| CFR Regulation Number | 870.2850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-01-05 |
| Decision Date | 1981-02-19 |