The following data is part of a premarket notification filed by Marquette Electronics, Inc. with the FDA for Non-invasive Blood Pressure Module.
Device ID | K894945 |
510k Number | K894945 |
Device Name: | NON-INVASIVE BLOOD PRESSURE MODULE |
Classification | System, Measurement, Blood-pressure, Non-invasive |
Applicant | MARQUETTE ELECTRONICS, INC. P.O. BOX 9100 100 MARQUETTE DRIVE Jupiter, FL 33468 |
Contact | Sandra Schick |
Correspondent | Sandra Schick 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 | 1989-08-03 |
Decision Date | 1989-10-26 |