Vitalograph Hand Held Spirometer, Model 2120
by Vitalograph Ireland, Ltd. 510(k)
Active
510(k) K100687
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK100687 | Date16 Oct 2010 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- 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
- FDA applicant
- Vitalograph (Ireland) , Ltd.
- Device Class
- Class II
- Regulation
- 21 CFR Part 868.1840
- Advisory Committee
- Anesthesiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Vitalograph Hand-Held Spirometer Model 2120 is a diagnostic device classified as a spirometer, designed to measure lung function parameters such as forced vital capacity (FVC) and forced expiratory volume in one second (FEV1). It evaluates respiratory health by assessing airflow and volume during forced exhalation, aiding in the diagnosis and monitoring of conditions like asthma and chronic obstructive pulmonary disease (COPD).
This handheld device is intended for use in clinical settings by trained professionals, including doctors’ offices, clinics, and hospital departments. Supplied as a reusable medical instrument, it requires proper calibration and maintenance to ensure accurate readings. The device adheres to regulatory standards, including FDA 510(k) clearance under the Anesthesiology Advisory Committee, and complies with relevant medical device regulations. No specific sterility or MRI safety information is provided in the data.
Other devices from Vitalograph Ireland, Ltd.
Questions
AI-generated answers, 19 Sep 2026
What clinical conditions is the Vitalograph Hand-Held Spirometer Model 2120 primarily used to evaluate?
The Vitalograph Hand-Held Spirometer Model 2120 is designed to measure lung function parameters like forced vital capacity (FVC) and forced expiratory volume in one second (FEV1), which help assess airflow and volume during forced exhalation. It is particularly useful for diagnosing and monitoring respiratory conditions such as asthma and chronic obstructive pulmonary disease (COPD).
Is the Vitalograph Hand-Held Spirometer Model 2120 intended for single-use or reusable applications?
The Vitalograph Hand-Held Spirometer Model 2120 is explicitly described as a reusable medical instrument. To ensure accurate readings, it requires proper calibration and maintenance, which is consistent with the expectations for reusable diagnostic devices.
How is the regulatory clearance for the Vitalograph Hand-Held Spirometer Model 2120 structured?
The device holds FDA 510(k) clearance under the Anesthesiology Advisory Committee (AN), with a decision classification of 'Substantially Equivalent' (SESE). This clearance was granted through a traditional review process, and the product code assigned is BZG, which aligns with its classification as a diagnostic spirometer.
What type of settings is the Vitalograph Hand-Held Spirometer Model 2120 intended for, and who should operate it?
The device is intended for use in clinical settings such as doctors’ offices, clinics, and hospital departments. It is designed for trained professionals, including healthcare providers who specialize in respiratory health assessments, to perform accurate lung function tests.
Does the Vitalograph Hand-Held Spirometer Model 2120 come with any specific sterility or MRI safety information?
The provided data does not include any details regarding sterility requirements or MRI safety for the Vitalograph Hand-Held Spirometer Model 2120. Users should follow standard infection control protocols for reusable medical devices and consult manufacturer guidelines for safe handling.