The following data is part of a premarket notification filed by Allied Healthcare Products, Inc. with the FDA for L.a.p. Ii Spriometry System.
Device ID | K932936 |
510k Number | K932936 |
Device Name: | L.A.P. II SPRIOMETRY SYSTEM |
Classification | Spirometer, Diagnostic |
Applicant | ALLIED HEALTHCARE PRODUCTS, INC. 1720 SUBLETTE AVE. St. Louis, MO 63110 |
Contact | Tim Davis |
Correspondent | Tim Davis ALLIED HEALTHCARE PRODUCTS, INC. 1720 SUBLETTE AVE. St. Louis, MO 63110 |
Product Code | BZG |
CFR Regulation Number | 868.1840 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-06-16 |
Decision Date | 1994-02-10 |