The following data is part of a premarket notification filed by Sharp Electronics Corp. with the FDA for (mb-650) Blood Pressure Monitor.
| Device ID | K880715 |
| 510k Number | K880715 |
| Device Name: | (MB-650) BLOOD PRESSURE MONITOR |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | SHARP ELECTRONICS CORP. P.O.BOX 650 Mahwah, NJ 07430 |
| Contact | E Sabella |
| Correspondent | E Sabella SHARP ELECTRONICS CORP. P.O.BOX 650 Mahwah, NJ 07430 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-02-09 |
| Decision Date | 1988-05-09 |