510(k) K810716
K810716 is an FDA 510(k) premarket notification submitted by Instrumentation Camera, Inc. for the device "X-RAY IMAGE INTENSIFIER PRODUCTS". The FDA issued a decision of Substantially Equivalent on April 23, 1981. The device falls under product code JAA (System, X-Ray, Fluoroscopic, Image-Intensified), a Class II device regulated under 21 CFR 892.1650. Instrumentation Camera, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 23, 1981
- Date Received
- March 17, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, X-Ray, Fluoroscopic, Image-Intensified
- Device Class
- Class II
- Regulation Number
- 892.1650
- Review Panel
- RA
- Submission Type