The following data is part of a premarket notification filed by Marquette Electronics, Inc. with the FDA for Non-invasive Bp Module 7000.
| Device ID | K841336 |
| 510k Number | K841336 |
| Device Name: | NON-INVASIVE BP MODULE 7000 |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | MARQUETTE ELECTRONICS, INC. P.O. BOX 9100 100 MARQUETTE DRIVE Jupiter, FL 33468 |
| Contact | Phillip T Weinfurt |
| Correspondent | Phillip T Weinfurt MARQUETTE ELECTRONICS, INC. P.O. BOX 9100 100 MARQUETTE DRIVE Jupiter, FL 33468 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-04-02 |
| Decision Date | 1984-10-26 |