510(k) K940284

MEDDEV MULTARRAY MEDICAL EXAMINING LIGHT MODIFICATION by Meddev International Corp. — Product Code KZF

K940284 is an FDA 510(k) premarket notification submitted by Meddev International Corp. for the device "MEDDEV MULTARRAY MEDICAL EXAMINING LIGHT MODIFICATION". The FDA issued a decision of Substantially Equivalent on February 28, 1994. The device falls under product code KZF (Device, Medical Examination, Ac Powered), a Class I device regulated under 21 CFR 880.6320. Meddev International Corp. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 28, 1994
Date Received
January 4, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Medical Examination, Ac Powered
Device Class
Class I
Regulation Number
880.6320
Review Panel
HO
Submission Type