# K062974: Tesla Nibp

- Pathway: 510(k) (Traditional)
- Applicant: Mammendorfer Institut Fur Physik Und Medizin GmbH
- Decided: Aug 13, 2007 after 318 days
- Product code: DXN (System, Measurement, Blood-Pressure, Non-Invasive)
- Device class: 2
- Regulation: 21 CFR 870.1130
- Recalls of this device: none
- 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) Omega TM 1400 MRI monitoring system: named in the summary without a submission number
- (no number) Omron HEM 711AC: named in the summary without a submission number

## Indications for use
The TeslaNBP monitor is an automatic oscillometric measuring system designed to take non-invasive blood pressure measurements. It measures systolic pressure, diastolic pressure, mean arterial pressure and heart rate. The TesldaNIBpm onitor is intended to be used on neonate, pediatric and adult populations during MR-examinations at a maximum magnetic field strength of 2OmT.

Source page: https://510kreport.com/device/K062974
Methodology: https://510kreport.com/methodology