510(k) K931483
K931483 is an FDA 510(k) premarket notification submitted by Portable Power Systems, Inc. for the device "REPLACEMENT BATERY FOR GE AMX-4 PORT. X-RAY MACH.". The FDA issued a decision of Substantially Equivalent on February 17, 1994. The device falls under product code IZL (System, X-Ray, Mobile), a Class II device regulated under 21 CFR 892.1720. Portable Power Systems, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 17, 1994
- Date Received
- March 24, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, X-Ray, Mobile
- Device Class
- Class II
- Regulation Number
- 892.1720
- Review Panel
- RA
- Submission Type