The following data is part of a premarket notification filed by Healthcheck Corp. with the FDA for Healthcheck Auto Inflate Digital Bp Monitor Bp-2.
| Device ID | K850070 |
| 510k Number | K850070 |
| Device Name: | HEALTHCHECK AUTO INFLATE DIGITAL BP MONITOR BP-2 |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | HEALTHCHECK CORP. 150 SANDBANK RD. Cheshire, CT 06410 |
| Contact | David R Balzer |
| Correspondent | David R Balzer 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 | 1985-01-04 |
| Decision Date | 1985-01-22 |