510(k) K883848

KMI OXY-BAN by Knight Medical, Inc. — Product Code KPJ

K883848 is an FDA 510(k) premarket notification submitted by Knight Medical, Inc. for the device "KMI OXY-BAN". The FDA issued a decision of SN on March 2, 1989. The device falls under product code KPJ (Chamber, Oxygen, Topical, Extremity), a Class II device regulated under 21 CFR 878.5650. Knight Medical, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SN ()
Decision Date
March 2, 1989
Date Received
September 12, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Chamber, Oxygen, Topical, Extremity
Device Class
Class II
Regulation Number
878.5650
Review Panel
SU
Submission Type