# K953175: AS/3 Estpr Module

- Pathway: 510(k) (Traditional)
- Applicant: Datex Division Instrumentarium Corp.
- Decided: Feb 6, 1997 after 580 days
- Product code: MLD (Monitor, St Segment With Alarm)
- Device class: 2
- Regulation: 21 CFR 870.1025
- 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 no predicate by number.

## Indications for use
The AS/3™ ESTPR module is intended to be used in the Datex AS/3™ Anaesthesia Monitor or in the AS/3™ Compact Monitor in anesthesia department, in recovery rooms, operation theatres etc.

Source page: https://510kreport.com/device/K953175
Methodology: https://510kreport.com/methodology