The following data is part of a premarket notification filed by Dio-med Corp. with the FDA for Disposable Diaphragm Domes.
| Device ID | K813267 |
| 510k Number | K813267 |
| Device Name: | DISPOSABLE DIAPHRAGM DOMES |
| Classification | Transducer, Blood-pressure, Extravascular |
| Applicant | DIO-MED CORP. 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 | 1981-11-20 |
| Decision Date | 1981-12-14 |