The following data is part of a premarket notification filed by Medex, Inc. with the FDA for Disposable Diaphragm Domes.
| Device ID | K820355 |
| 510k Number | K820355 |
| Device Name: | DISPOSABLE DIAPHRAGM DOMES |
| 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 | 1982-02-08 |
| Decision Date | 1982-03-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 35019517090417 | K820355 | 000 |
| 50351688504669 | K820355 | 000 |
| 50351688505062 | K820355 | 000 |
| 50351688504690 | K820355 | 000 |
| 50351688517881 | K820355 | 000 |
| 50351688504713 | K820355 | 000 |
| 50351688510738 | K820355 | 000 |