Vitalograph-Alpha Spirometer
by Vitalograph, Ltd. 510(k)
Active
510(k) K873562
Overview
The Vitalograph-Alpha is a diagnostic spirometer designed to measure expiratory parameters of forced tests, such as Forced Vital Capacity (FVC), and slow tests, such as Tidal Volume (Vt). It employs a pneumotachograph flowhead to assess airflow dynamics, providing dynamic visual feedback via a liquid crystal display on the instrument’s front panel. The device is classified as a Class II medical device under FDA regulations and is intended for use in respiratory function assessments.
The Vitalograph-Alpha is supplied as a reusable device and is intended for use in clinical settings, including hospitals and pulmonary function laboratories. It operates using software cartridges that influence test results, and printed outputs of test data can be generated. The device is regulated under FDA 510(k) clearance (K873562) and adheres to the regulatory requirements outlined in 21 CFR 868.1840. No specific sterility or MRI safety information is provided in the available data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK873562 | Date29 Aug 1988 | 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- Withdrawn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
- Full name
- Vitalograph-Alpha
- 510(k) Number
- FDA Product Code
- BZG
- FDA applicant
- Vitalograph , Ltd.
- 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-Alpha used for?
The Vitalograph-Alpha is a diagnostic spirometer designed to measure expiratory parameters like Forced Vital Capacity (FVC) and slow tests such as Tidal Volume (Vt). It assesses airflow dynamics using a pneumotachograph flowhead and provides dynamic visual feedback via an LCD display. This makes it suitable for respiratory function assessments in clinical settings like hospitals and pulmonary function laboratories.
Is the Vitalograph-Alpha reusable or single-use?
The Vitalograph-Alpha is supplied as a reusable device. It is intended for use in clinical environments where multiple patients may require testing, and it is designed to withstand repeated use under proper maintenance and cleaning protocols.
How does the Vitalograph-Alpha generate test results?
The Vitalograph-Alpha operates using software cartridges that influence the test results. Additionally, printed outputs of the test data can be generated for documentation and review purposes, ensuring accurate record-keeping for clinical assessments.
Are there any specific sterility or MRI safety requirements for the Vitalograph-Alpha?
The available data does not provide specific information regarding sterility or MRI safety for the Vitalograph-Alpha. Users should follow standard clinical practices for cleaning and maintenance to ensure device reliability and patient safety.
What regulatory pathway does the Vitalograph-Alpha follow?
The Vitalograph-Alpha is regulated under the FDA 510(k) clearance pathway, specifically with clearance number K873562. It is classified as a Class II medical device and adheres to the regulatory requirements outlined in 21 CFR 868.1840.