L.A.P. II Spriometry System
by Allied Healthcare Products, Inc.
510(k) K932936
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK932936 | Date10 Feb 1994 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
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
Overview
AI-generated summary, 27 Sep 2026
The L.A.P. II Spirometry System is a diagnostic spirometer. It is designed to measure and record the volume and flow of air inhaled and exhaled by a patient to assist in clinical assessment.
This device is classified as an FDA class 2 medical device under regulation number 868.1840. It received FDA 510(k) clearance on February 10, 1994, under the application number K932936.
Other devices from Allied Healthcare Products, Inc.
Questions
AI-generated answers, 27 Sep 2026
What is the primary function of the L.A.P. II Spirometry System?
This device is a diagnostic spirometer intended to measure and record the volume and flow of air inhaled and exhaled by a patient. It is used to assist clinicians in performing patient assessments.
What is the regulatory classification of this device?
The L.A.P. II Spirometry System is classified as an FDA class 2 medical device under regulation number 868.1840. It received FDA 510(k) clearance on February 10, 1994, under application number K932936.
Who is the manufacturer of the L.A.P. II Spirometry System?
The device is manufactured by Allied Healthcare Products, Inc., located in Saint Louis, Missouri.