The following data is part of a premarket notification filed by Graphic Controls Corp. with the FDA for Medi-trace Disposable Domes/monitoring.
| Device ID | K800706 |
| 510k Number | K800706 |
| Device Name: | MEDI-TRACE DISPOSABLE DOMES/MONITORING |
| Classification | Transducer, Blood-pressure, Extravascular |
| Applicant | GRAPHIC CONTROLS 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 | 1980-03-31 |
| Decision Date | 1980-04-16 |