510(k) K940284
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