510(k) K874750
K874750 is an FDA 510(k) premarket notification submitted by Scientific Imaging, Inc. for the device "VIDEO ANALYZER 4000". The FDA issued a decision of Substantially Equivalent on April 25, 1988. The device falls under product code IBJ (Light, Microscope), a Class I device regulated under 21 CFR 864.3600. Scientific Imaging, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 25, 1988
- Date Received
- November 18, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Light, Microscope
- Device Class
- Class I
- Regulation Number
- 864.3600
- Review Panel
- PA
- Submission Type