The following data is part of a premarket notification filed by Sharp Electronics Corp. with the FDA for Md308h Digital/mb351h Auto-bp Monitor.
| Device ID | K842200 |
| 510k Number | K842200 |
| Device Name: | MD308H DIGITAL/MB351H AUTO-BP MONITOR |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | SHARP ELECTRONICS CORP. P.O. BOX 588 Paramus , NJ 07652 - |
| Contact | Glen L Weinberg |
| Correspondent | Glen L Weinberg SHARP ELECTRONICS CORP. 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 | 1984-06-04 |
| Decision Date | 1984-10-24 |