510(k) K832185

OHIO MODEL 922 SPIROMETER by Airco/Ohio Medical Products — Product Code BZG

K832185 is an FDA 510(k) premarket notification submitted by Airco/Ohio Medical Products for the device "OHIO MODEL 922 SPIROMETER". The FDA issued a decision of Substantially Equivalent on August 12, 1983. The device falls under product code BZG (Spirometer, Diagnostic), a Class II device regulated under 21 CFR 868.1840. Airco/Ohio Medical Products has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 12, 1983
Date Received
July 6, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Spirometer, Diagnostic
Device Class
Class II
Regulation Number
868.1840
Review Panel
AN
Submission Type