The following data is part of a premarket notification filed by Sharp Electronics Corp. with the FDA for Model Mb-500 & Mb-600 Blood Pressure Monitors.
| Device ID | K861375 |
| 510k Number | K861375 |
| Device Name: | MODEL MB-500 & MB-600 BLOOD PRESSURE MONITORS |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | SHARP ELECTRONICS CORP. 10 SHARP PLAZA P.O. BOX 588 Paramus, NJ 07652 |
| Contact | Glen L Weinberg |
| Correspondent | Glen L Weinberg SHARP ELECTRONICS CORP. 10 SHARP PLAZA P.O. BOX 588 Paramus, NJ 07652 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-01-27 |
| Decision Date | 1986-08-06 |