# K983250: Invasive Blood Pressure (Ibp) Function, Model 9500 Multigas Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Magnetic Resonance Equipment Corp.
- Decided: Dec 12, 1999 after 452 days
- Product code: DSK (Computer, Blood-Pressure)
- Device class: 2
- Regulation: 21 CFR 870.1110
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) BCI Model 9100 Multigas Monitor with Invasive Blood Pressure function: named in the summary without a submission number

## Recalls of this device
- Sep 29, 2006 · Not classified · Z-0258-2007: Interference problems: certain invasive blood pressure transducers connected to these cables are susceptible to interference if exposed to static magnetic field strengths exceeding 300 gauss. In certa

## Indications for use
Invasive blood pressure function is an option for the Model 9500 Multigas monitor. This function would be used when a clinician determined the need for continuous monitoring of arterial or venous blood pressure for adult patients undergoing MRI examination.

Source page: https://510kreport.com/device/K983250
Methodology: https://510kreport.com/methodology