510(k) K823257

NON-REUSABLE UNIVERSAL NEBULIZER FILTE by Ohio Medical Products — Product Code CAH

K823257 is an FDA 510(k) premarket notification submitted by Ohio Medical Products for the device "NON-REUSABLE UNIVERSAL NEBULIZER FILTE". The FDA issued a decision of Substantially Equivalent on December 9, 1982. The device falls under product code CAH (Filter, Bacterial, Breathing-Circuit), a Class II device regulated under 21 CFR 868.5260. Ohio Medical Products has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 9, 1982
Date Received
November 1, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Filter, Bacterial, Breathing-Circuit
Device Class
Class II
Regulation Number
868.5260
Review Panel
HO
Submission Type