Panda Helium Gas Analyzer
by Medical Associated Services, Inc.
510(k) K903939
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK903939 | Date3 Jan 1991 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- BSE
- Device Class
- Class II
- Regulation
- 21 CFR Part 868.1640
- Advisory Committee
- Anesthesiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 24 Sep 2026
A helium gas analyzer is a device intended to measure the concentration of helium in a gas mixture during pulmonary function testing. The device may use techniques such as thermal conductivity, gas chromatography, or mass spectrometry.
The Panda Helium Gas Analyzer (K903939) received FDA 510(k) clearance on January 3, 1991, under product code BSE and regulation number 868.1640. It is classified as a Class II device and was found substantially equivalent to a predicate device. The device is used in anesthesiology and respiratory care settings for gas analysis.
Other devices from Medical Associated Services, Inc.
Questions
AI-generated answers, 24 Sep 2026
What is the Panda Helium Gas Analyzer used for?
The Panda Helium Gas Analyzer is intended to measure the concentration of helium in a gas mixture during pulmonary function testing, helping assess lung volumes and ventilation distribution in anesthesiology and respiratory care settings.
How does the Panda Helium Gas Analyzer measure helium concentration?
The device uses techniques such as thermal conductivity, gas chromatography, or mass spectrometry to determine helium concentration in gas mixtures, providing accurate readings for pulmonary function assessments.
What regulatory pathway was used for the Panda Helium Gas Analyzer K903939?
The Panda Helium Gas Analyzer (K903939) received FDA 510(k) clearance on January 3, 1991, under product code BSE and regulation number 868.1640, demonstrating substantial equivalence to a predicate device.