# K954980: Pagewriter 200, 200I Cardiograph & Interpretive Cardio

- Pathway: 510(k) (Traditional)
- Applicant: Hewlett-Packard Co.
- Decided: May 15, 1996 after 197 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 K895520 (1990). 2 ancestors in all.
8 later devices descend from it; 4 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K895520: Pagewriter Xli M1700A & Pagewriter XL M1701A, Hewlett-Packard Co. (1990) Summary page 2.
- K941282: Ecg Fax Modem, Hewlett-Packard Co. (1995) Summary page 1.
- (no number) PageWriter 200i (Model M1770A): named in the summary without a submission number
- (no number) PageWriter 200 (Model M1771A): named in the summary without a submission number

## Most influential descendants
- K032200: Elan Digital 12 Channel Electrocardiograph (2003), 6 descendants of its own
- K072353: Portable Ecscope (2007), 5 descendants of its own
- K080036: Portable Ecscope 12I (2008), 2 descendants of its own
- K082013: Clue Medical and Clue Medical Basic (2008), 1 descendant of its own
- K091397: Ecscope 200 (2009), 0 descendants of its own

## Indications for use
The PageWriter 200 series cardiographs with option #A05 transmit ECGs for management or physician review or copying. ECGs can be transmitted to another PageWriter cardiograph or to a general purpose fax device. Option #A05 also provides ECG storage capability in the cardiograph. The intended use of the PageWriter 200i and 200 with option #A05 is substantially equivalent to the intended use of the PageWriter XLi with Direct Digital FAX (Model M1706B) currently marketed which received FDA's substantial equivalence determination under K#941282, i.e., it is intended to be used to transmit ECGs for management or physician review or copying and transmit to another device. The PageWriter 200i and 200 with option #A05 is intended to be used in a hospital environment or in a physician's office. The cardiograph is used to acquire, digitize, record, and transmit conventional diagnostic 12 simultaneous lead ECG waveforms and ECG data. The cardiograph also records patient data entered through the alphanumeric keyboard. Additionally, the PageWriter 200i cardiograph measures and provides ECG interpretation. The 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.

Source page: https://510kreport.com/device/K954980
Methodology: https://510kreport.com/methodology