REPLACEMENT BATERY FOR GE AMX-4 PORT. X-RAY MACH.

REPLACEMENT BATERY FOR GE AMX-4 PORT. X-RAY MACH. is an FDA 510(k)-cleared medical device (K931483) manufactured by Portable Power Systems, Inc.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 16, 1994. Regulation: 8.