510(k) K896923

INTERTECH/INSPIRON (R) MEDICATION NEBULIZER KIT by Intertech Resources, Inc. — Product Code CAF

K896923 is an FDA 510(k) premarket notification submitted by Intertech Resources, Inc. for the device "INTERTECH/INSPIRON (R) MEDICATION NEBULIZER KIT". The FDA issued a decision of SN on March 12, 1990. The device falls under product code CAF (Nebulizer (Direct Patient Interface)), a Class II device regulated under 21 CFR 868.5630. Intertech Resources, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SN ()
Decision Date
March 12, 1990
Date Received
December 12, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nebulizer (Direct Patient Interface)
Device Class
Class II
Regulation Number
868.5630
Review Panel
AN
Submission Type