# K982550: Browser (Event Software) Model # 4500E

- Pathway: 510(k) (Traditional)
- Applicant: Respironics, Inc.
- Decided: Oct 5, 1998 after 75 days
- Product code: BZQ (Monitor, Breathing Frequency)
- Device class: 2
- Regulation: 21 CFR 868.2375
- 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 K892006 (1989). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K892006: Healthdyne's Apnea/Heart Monitor, Model 900S, Healthdyne, Inc. (1989) Summary page 1.

## Cited in the summary but kept off the family tree
- K903287: Model 900S Apnea/Heart Monitor, Healthdyne, Inc. (1990). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
Browser is a software program that is used by a HCP (Healthcare Professional) to view, analyze, and edit patient data gathered with a SmartMonitor® Infant Apnea Monitor. Information that is collected includes patient information, equipment parameters, compliance logs, patient events, equipment events, and waveforms. The data is downloaded to a PC, either by direct connection to the monitor or by modem. The data can also be retrieved from a computer file or memory disk such as a floppy or card. The software allows the user to review and manipulate event information, produce reports, save changes, and forward data via e-mail.

Source page: https://510kreport.com/device/K982550
Methodology: https://510kreport.com/methodology