The following data is part of a premarket notification filed by Sharp Electronics Corp. with the FDA for Sharp Digital Bp Monitor Mb-371h.
| Device ID | K850830 |
| 510k Number | K850830 |
| Device Name: | SHARP DIGITAL BP MONITOR MB-371H |
| 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 | 1985-02-06 |
| Decision Date | 1985-06-13 |