510(k) K914397
K914397 is an FDA 510(k) premarket notification submitted by Dia-Stron, Ltd. for the device "OXFORD OPTRONIX MPM 3S". The FDA issued a decision of Substantially Equivalent on November 16, 1992. The device falls under product code FTI (Lamp, Endoscope, Incandescent), a Class II device regulated under 21 CFR 876.1500.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 16, 1992
- Date Received
- October 1, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Lamp, Endoscope, Incandescent
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type