The following data is part of a premarket notification filed by Airco/ohio Medical Products with the FDA for Ohio Model 922 Spirometer.
Device ID | K832185 |
510k Number | K832185 |
Device Name: | OHIO MODEL 922 SPIROMETER |
Classification | Spirometer, Diagnostic |
Applicant | AIRCO/OHIO MEDICAL PRODUCTS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | BZG |
CFR Regulation Number | 868.1840 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-07-06 |
Decision Date | 1983-08-12 |