The following data is part of a premarket notification filed by Narco Scientific with the FDA for Non-invasive Automatic Blood Pressure.
| Device ID | K821378 |
| 510k Number | K821378 |
| Device Name: | NON-INVASIVE AUTOMATIC BLOOD PRESSURE |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | NARCO SCIENTIFIC 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-05-10 |
| Decision Date | 1982-07-08 |