Flowhandy ZAN100 USB
by Zan Messgerate GmbH 510(k)
Active
510(k) K052176
Overview
The Flowhandy Zan100 USB is a diagnostic spirometer designed for measuring and analyzing breath flow, volume, and pressure in adult and pediatric subjects. It is an open, personal-computer-based spirometry system with an optional shutter for respiratory assessment.
It is supplied by Zan Messgerate GmbH and was cleared under FDA 510(k) K052176 on January 12, 2006, as substantially equivalent to a predicate device. The device is classified as Class II under regulation number 868.1840 and is intended for use in clinical settings by pulmonologists, allergists, and general practitioners.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK052176 | Date12 Jan 2006 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- BZG
- Device Class
- Class II
- Regulation
- 21 CFR Part 868.1840
- Advisory Committee
- Anesthesiology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Zan Messgerate GmbH
Questions
What is the Flowhandy Zan100 USB used for?
The Flowhandy Zan100 USB is a diagnostic spirometer designed for measuring and analyzing breath flow, volume, and pressure in adult and pediatric subjects. It is intended for use in clinical settings by pulmonologists, allergists, and general practitioners to assess respiratory function.
How is the Flowhandy Zan100 USB supplied and what type of system is it?
The Flowhandy Zan100 USB is supplied by Zan Messgerate GmbH as an open, personal-computer-based spirometry system. It includes an optional shutter for respiratory assessment and connects via USB to a computer for operation and data analysis.
What regulatory pathway was used for the Flowhandy Zan100 USB and when was it cleared?
The Flowhandy Zan100 USB was cleared under the FDA 510(k) pathway as substantially equivalent to a predicate device, with clearance granted on January 12, 2006, under k-number K052176. It is classified as a Class II medical device under regulation number 868.1840.