Vitalograph Model 2120
by Vitalograph, Inc. 510(k)
Active
510(k) K946075
Overview
The Vitalograph Model 2120 is a handheld spirometer used for diagnostic lung function testing. It measures forced vital capacity (FVC) and vital capacity (VC) before and after bronchodilator administration. This portable device is designed for use in various settings including medical offices, hospitals, workplaces, and homes.
The device is supplied with a rechargeable battery and communications cradle, with an optional smart feature for automating actions. It is a Class II medical device cleared by the FDA under 510(k) K946075 for the product code BZG. The device is intended for single-use testing and requires appropriate storage conditions as specified by the manufacturer.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK946075 | Date4 Aug 1995 | 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- Withdrawn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 Vitalograph, Ltd.
Questions
What is the Vitalograph Model 2120 used for?
The Vitalograph Model 2120 is a handheld spirometer used for diagnostic lung function testing. It measures forced vital capacity (FVC) and vital capacity (VC) before and after bronchodilator administration in various settings including medical offices, hospitals, workplaces, and homes.
How is the Vitalograph Model 2120 supplied?
The device is supplied with a rechargeable battery and communications cradle. An optional smart feature is available for automating actions, making it convenient for different testing environments and data management needs.
Is the Vitalograph Model 2120 a single-use device?
The Vitalograph Model 2120 is intended for single-use testing, meaning each test should be performed with appropriate infection control measures. The device itself is reusable, but each testing session should follow proper hygiene protocols.
What are the storage requirements for the Vitalograph Model 2120?
The device requires appropriate storage conditions as specified by the manufacturer. While specific temperature ranges aren't provided in the data, users should store the device in a clean, dry environment away from extreme temperatures to maintain optimal performance and battery life.
What is the regulatory status of the Vitalograph Model 2120?
The Vitalograph Model 2120 is a Class II medical device cleared by the FDA under 510(k) K946075 for product code BZG. It has been determined to be substantially equivalent to other legally marketed devices for its intended use in diagnostic lung function testing.