BATTERY PACK

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 Battery Pack.

Pre-market Notification Details

Device IDK924798
510k NumberK924798
Device Name:BATTERY PACK
ClassificationSystem, X-ray, Mobile
Applicant PORTABLE POWER SYSTEMS, INC. 10336 SOUTH DRANSFELDT RD. Parker,  CO  80134
ContactNorman A Premo
CorrespondentNorman A Premo
PORTABLE POWER SYSTEMS, INC. 10336 SOUTH DRANSFELDT RD. Parker,  CO  80134
Product CodeIZL  
CFR Regulation Number892.1720 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-09-24
Decision Date1992-10-16

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