L.A.P. II Spriometry System
FDA 510(k) K932936 · Allied Healthcare Products, Inc.
510(k) numberK932936
Submission
- Device name
- L.A.P. II Spriometry System
- Applicant
- Allied Healthcare Products, Inc.
Saint Louis, MO, US - Received
- June 16, 1993
- Decision date
- February 10, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- BZG – Spirometer, Diagnostic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1840
- Specialty
- Anesthesiology
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Questions and answers
When was L.A.P. II Spriometry System cleared by the FDA?
L.A.P. II Spriometry System (K932936) received a 510(k) decision of Substantially Equivalent on February 10, 1994, 239 days after the submission was received.
What is the product code of K932936?
The FDA product code is BZG – Spirometer, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 868.1840.