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

System, X-ray, Mobile

PORTABLE POWER SYSTEMS, INC.

The following data is part of a premarket notification filed by Portable Power Systems, Inc. with the FDA for Replacement Batery For Ge Amx-4 Port. X-ray Mach..

Pre-market Notification Details

Device IDK931483
510k NumberK931483
Device Name:REPLACEMENT BATERY FOR GE AMX-4 PORT. X-RAY MACH.
ClassificationSystem, X-ray, Mobile
Applicant PORTABLE POWER SYSTEMS, INC. 1949 TEE LN. Castle Rock,  CO  80104
ContactNorman A Premo
CorrespondentNorman A Premo
PORTABLE POWER SYSTEMS, INC. 1949 TEE LN. Castle Rock,  CO  80104
Product CodeIZL  
CFR Regulation Number892.1720 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-03-24
Decision Date1994-02-17

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.