# K981265: Pagewriter 200I Interpretive Cardiograph Model M1770A with Acute Cardiac Ischemia Time Insensitive Predictive Instrumena

- Pathway: 510(k) (Traditional)
- Applicant: Hewlett-Packard Co.
- Decided: Jun 23, 1998 after 77 days
- Product code: LOS
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K935772 (1994). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951978: Hewlett-Packard Model M1791A Acute Cardiac Ischemia-Time Insensitive Predicitive Instrument (Aci-Tipt), Hewlett-Packard Co. (1996) Summary page 2.
- K935772: HP M177XA Cardiographs, Hewlett-Packard Co. (1994) Summary page 2.

## Most influential descendants
- K982025: Hewlett-Packard M2475B with 12-Lead Option (#C90) Codemaster 100 Conitor/Defibrillator (1998), 0 descendants of its own

## Indications for use
The PageWriter 200i Model M1770A is intended to provide acquisition, digitization and recording of conventional diagnostic 12 simultaneous lead ECG waveforms and ECG Data, The PageWriter 200i Model M1770A also displays ECG waveforms and records patient information entered through the alphanumeric keyboard. Additionally, it measures and provides interpretation. The PageWriter 200i Model M1770A interpreted ECG with measurements and diagnostic statements is offered to the physician on an advisory basis only, and the physician is asked to overread and validate (or change) the ECG interpretation. In addition, the PageWriter 200i Model M1770A with ACI-TIPI Model M1791A is intended to provide the cardiologist with an additional tool to aid in assessment of acute cardiac ischemia.

Source page: https://510kreport.com/device/K981265
Methodology: https://510kreport.com/methodology