The following data is part of a premarket notification filed by Healthcheck Corp. with the FDA for Pulsonic Digital Blood Pressure Monitor Model Bp-3.
| Device ID | K860287 |
| 510k Number | K860287 |
| Device Name: | PULSONIC DIGITAL BLOOD PRESSURE MONITOR MODEL BP-3 |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | HEALTHCHECK CORP. 150 SANDBANK RD. Cheshire, CT 06410 |
| Contact | Balzer, Jr. |
| Correspondent | Balzer, Jr. HEALTHCHECK CORP. 150 SANDBANK RD. Cheshire, CT 06410 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-01-28 |
| Decision Date | 1986-04-28 |