# K973437: Hewlett-Packard Models M1001B Ecg M1002B Ecg/Respiration Plug-in Modules

- Pathway: 510(k) (Traditional)
- Applicant: Hewlett-Packard GmbH
- Decided: Dec 3, 1997 after 84 days
- Product code: DPS (Electrocardiograph)
- Device class: 2
- Regulation: 21 CFR 870.2340
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
510 later devices descend from it; 1 cites it directly.
0 of 511 devices 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.

## Most influential descendants
- K990125: HP Viridia Component Monitoring System, Model Rev. K (1999), 509 descendants of its own
- K990972: HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia Multi-Measurement Server and Compact Portable T (1999), 462 descendants of its own
- K992273: HP Viridia Multi-Measurement Server/Compact Portable Patient Monitor M3000A/M3046A/M3016A,Rel B (2000), 451 descendants of its own
- K013199: Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model M1276B (2001), 431 descendants of its own
- K021300: Modification of Philips Component Compact Monitor, Release a.03, Model M1275B (2002), 421 descendants of its own

## Indications for use
The HP M1001B/M1002B ECG Plug-in Modules together with the Patient Monitor M1175A/M1176A are indicated for use in health care facilities by health care professionals when the patient’s clinician deems it appropriate to use a device that: a) Can measure and display multiple physiological parameters and waves' of one patient, and can generate alarms and printouts based on those measurements. b) Can be used on adult, pediatric, and neonatal patients as specified in the Technical Data Sheets. 1. List of supported measurements (a) ECG o (b) Respiration

Source page: https://510kreport.com/device/K973437
Methodology: https://510kreport.com/methodology