Pneumoscope
by Erich Jaeger, Inc. 510(k)
Active
510(k) K852337
Overview
The Pneumoscope is a diagnostic spirometer used in pulmonary function testing to measure the volume of gas moving in or out of a patient's lungs. It is classified under product code BZG and is intended for use in anesthesiology settings.
The device is manufactured by Erich Jaeger, Inc. and received FDA 510(k) clearance on July 1, 1985, with K number K852337. It is classified as a Class II medical device and is substantially equivalent to predicate devices. The device is not specified as single-use or reusable, and no information regarding sterility, MRI safety, or storage conditions is provided in the data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK852337 | Date1 Jul 1985 | 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- Withdrawn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 Erich Jaeger GmbH
Questions
What is the Pneumoscope used for?
The Pneumoscope is a diagnostic spirometer used in pulmonary function testing to measure the volume of gas moving in or out of a patient's lungs, specifically intended for use in anesthesiology settings.
Is the Pneumoscope a single-use device or reusable?
The device data does not specify whether the Pneumoscope is single-use or reusable, indicating that this information is not provided in the available documentation.
What is the regulatory status of the Pneumoscope?
The Pneumoscope received FDA 510(k) clearance on July 1, 1985, with K number K852337, and is classified as a Class II medical device that is substantially equivalent to predicate devices.
What are the specifications of the Pneumoscope?
The Pneumoscope is classified under product code BZG and is manufactured by Erich Jaeger, Inc. It is intended for pulmonary function testing in anesthesiology settings, though specific measurements or technical specifications are not detailed in the provided data.