# K982676: Airwatch II Zone

- Pathway: 510(k) (Traditional)
- Applicant: Enact Health Management Systems
- Decided: Oct 29, 1998 after 90 days
- Product code: BZH (Meter, Peak Flow, Spirometry)
- Device class: 2
- Regulation: 21 CFR 868.1860
- 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 K941226 (1994). 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)
- K941226: Airwatch Monitor, Enact Health Management Systems (1994) Summary page 1.

## Indications for use
AirWatch II Zone is a medical instrument which is intended to be used for the monitoring of asthma and other chronic respiratory diseases. The instrument measures both Peak Expiratory Flow (PEF) and Forced Expiratory Volume-One Second (FEV1). The instrument is designed for use by consumers from 5 years of age to adults.

Source page: https://510kreport.com/device/K982676
Methodology: https://510kreport.com/methodology