510(k) K942019
K942019 is an FDA 510(k) premarket notification submitted by International Medical Designs, Inc. for the device "MODEL FP-100". The FDA issued a decision of Substantially Equivalent on February 1, 1995. The device falls under product code JAA (System, X-Ray, Fluoroscopic, Image-Intensified), a Class II device regulated under 21 CFR 892.1650. International Medical Designs, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 1, 1995
- Date Received
- April 26, 1994
- 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