510(k) K840209
K840209 is an FDA 510(k) premarket notification submitted by Litton Medical Electronics for the device "SERVOMED MEDIVISION SCOPE SMV-235". The FDA issued a decision of Substantially Equivalent on September 20, 1984. The device falls under product code DXJ (Display, Cathode-Ray Tube, Medical), a Class II device regulated under 21 CFR 870.2450. Litton Medical Electronics has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 20, 1984
- Date Received
- January 19, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Display, Cathode-Ray Tube, Medical
- Device Class
- Class II
- Regulation Number
- 870.2450
- Review Panel
- CV
- Submission Type