VACPLUS SUCTION UNIT

Apparatus, Suction, Ward Use, Portable, Ac-powered

APEX MEDICAL CORP.

The following data is part of a premarket notification filed by Apex Medical Corp. with the FDA for Vacplus Suction Unit.

Pre-market Notification Details

Device IDK103535
510k NumberK103535
Device Name:VACPLUS SUCTION UNIT
ClassificationApparatus, Suction, Ward Use, Portable, Ac-powered
Applicant APEX MEDICAL CORP. NO.8, LANE 29, WENMING RD. Guisan, Taoyuan,  TW 33383
Product CodeJCX  
CFR Regulation Number878.4780 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-12-01
Decision Date2011-02-24
Summary:summary

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