The following data is part of a premarket notification filed by Pharmaseal Div., Baxter Healthcare Corp. with the FDA for Monitoring, Pressure Kit.
| Device ID | K781680 |
| 510k Number | K781680 |
| Device Name: | MONITORING, PRESSURE KIT |
| Classification | Transducer, Blood-pressure, Extravascular |
| Applicant | PHARMASEAL DIV., BAXTER HEALTHCARE 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 | 1978-10-02 |
| Decision Date | 1978-10-06 |