510(k) K883848
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